Safety and Efficacy of Fish Oil–Enriched Parenteral Nutrition Regimen on Postoperative Patients Undergoing Major Abdominal Surgery

Background: To evaluate the safety and efficacy of a fish oil–enriched parenteral nutrition regimen in patients undergoing major abdominal surgery, a meta‐analysis of randomized controlled trials was conducted. Methods: An electronic search of PubMed, MEDLINE, EMBASE, Academic Search Premier, and China National Knowledge Infrastructure databases was performed in March 2009. RevMan 5.0 was used for statistical analysis. Results: The combined analysis showed that a fish oil–enriched parenteral nutrition regimen had a positive treatment effect on length of hospital stay (weighed mean difference = ?2.98, P < .001), length of intensive care unit stay, postoperative infection rate (odds ratio = 0.56, P = .04), and serum levels of aspartate aminotransferase, alanine aminotransferase, and α‐tocopherol on postoperative day 6 in these patients. The regimen increased the plasma levels of eicosapentaenoic acid (standardized mean difference = 3.11, P < .001) and docosahexaenoic acid and upregulated the leukotriene B₅ production in leukocytes on postoperative day 6. No significant differences were found between the 2 groups in postoperative mortality; incidence of postoperative cardiac complications; serum levels of bilirubin, triglyceride, or arachidonic acid; or the liberation of leukotriene B₄. No serious adverse events related to fish oil treatment were reported. Conclusions: Based on the meta‐analysis, fish oil–supplemented parenteral nutrition was safe, improved clinical outcomes, and altered the fatty acid pattern as well as leukotriene synthesis. More laboratory parameters should be considered in future meta‐analyses.     

When early enteral feeding is not possible in critically ill patients: results of a multicenter observational study

Background: Early enteral nutrition (EN) is the preferred strategy for feeding the critically ill; however, it is not always possible to initiate EN within the recommended 24 to 48 hours. When these situations arise, controversy exists whether to start feeding early via the parenteral route or to delay feeding until EN can be provided. Methods: A multicenter, international, observational study examined nutrition practices in intensive care units (ICUs). Eligible patients were critically ill patients with a medical diagnosis who remained in the ICU for >72 hours and received EN >48 hours after admission. Data were collected on site, including patient characteristics, daily nutrition practices, and outcomes at 60 days. Nutrition and clinical outcomes were compared between 3 groups of patients: (1) early parenteral nutrition (PN) (<48 hours after admission) and late EN (>48 hours after admission), (2) late PN and late EN, and (3) late EN and no PN. Results: Of the 703 patients who met our inclusion criteria, 541 (77.0%) medical patients received late EN and no PN. In patients receiving late EN and PN, 83 (11.8%) received early PN and 79 (11.2%) received late PN. Adequacy of calories and protein from total nutrition was highest in the early PN group (74.1% ± 21.2% and 71.5% ± 24.9%, respectively) and lowest in the late EN group (42.9% ± 21.2% and 38.7% ± 21.6%) (P < .001). The proportion of patients dead or remaining in hospital was significantly higher for early PN compared with late EN and PN (unadjusted hazard ratio for early PN = 0.55; 95% confidence interval, 0.37–0.83, P = .015). However, this difference did not remain significant (P = .65) after adjustment for baseline characteristics. Conclusions: The results suggest that initiating PN early, when it is not possible to feed enterally early, may improve provision of calories and protein but is not associated with better clinical outcomes compared with late EN or PN.     

Effect of Intestinal Atrophy and Hepatic Impairment Induced by Parenteral Nutrition on Drug Absorption and Disposition in Rats

Background: Long‐term parenteral nutrition (PN) has a high risk of hepatic dysfunction and intestinal atrophy. The present study investigated the effect of PN‐induced intestinal atrophy and hepatic impairment on drug pharmacokinetics by using 2 contrasting compounds: phenolsulfonphthalein (PSP) and cyclosporin A (CyA). Materials and Methods: PSP or CyA was administered to 7‐day PN‐fed Rats (PN rats) and sham operated rats (control rats) via intravenous (IV) or intraloop administration of the intestine. Pharmacokinetic parameters with 2‐compartment analysis including area under the concentration vs time curve (AUC) and the permeability after in situ intraloop administration (P_loop) were obtained from both concentration profiles after different administration routes. Results: After IV administration of PSP to control and PN rats, there was no notable difference in any of the pharmacokinetic parameters. In contrast, after intraloop administration, AUC and P_loop in PN rats were approximately 2.6‐ and 2.0‐fold higher than that in control rats, respectively. On the other hand, after IV administration of CyA, the terminal half‐life and total body clearance were prolonged and decreased in PN rats, respectively, resulting in 2.0‐fold increase in AUC. After intraloop administration, the AUC of PN rats was increased to approximately 1.3‐fold that of control rats, whereas no notable difference was observed in P_loop. Conclusion: The intestinal permeability of PSP was enhanced by intestinal atrophy induced by PN, while the metabolism of CyA was diminished by hepatic impairment by PN. These results revealed the physicochemical property‐based pharmacokinetic alterations during PN; for a more detailed understanding, however, further studies are needed.     

New Strategy to Reduce Hypertriglyceridemia During Parenteral Nutrition While Maintaining Energy Intake

Background: Hypertriglyceridemia is a frequent metabolic complication associated with fat administration in parenteral nutrition (PN). No clear guidelines have been published on how to proceed once hypertriglyceridemia has been detected. A new strategy could be to substitute the initial fat emulsion with another emulsion with faster clearance. Our objective was to determine the effectiveness in reducing triglyceridemia values, maintaining the caloric intake, and improving nutrition parameters in patients who had moderate hypertriglyceridemia during PN when an olive oil–based fat emulsion (OOFE) was substituted with a multiple‐source oil fat emulsion (MOFE). We also assessed the safety of this substitution in hepatic and glycemic profiles. Materials and Methods: We performed a retrospective, observational study that included 38 adult patients to whom OOFE in PN was substituted with MOFE when moderate hypertriglyceridemia (≥250–400 mg/dL) was detected. Results: Triglyceridemia values decreased in 36 (94.7%) patients. The mean reduction was 71 (88–22) mg/dL. Fat load was slightly reduced after substitution (–0.14 [–0.23 to 0] g/kg/d; P < .001), but total caloric intake increased from 22.5 (19.7–25.1) to 23.1 (19.8–26.8) kcal/kg/d (P = .053). After substitution, nutrition parameters improved, liver parameters remained unchanged, and insulin requirements increased. Conclusion: The substitution of OOFE with MOFE in patients with moderate hypertriglyceridemia during PN resulted in a reduction in triglyceridemia values of about 70 mg/dL. That allowed maintaining the caloric intake and improved nutrition parameters without affecting the hepatic profile. For some patients, insulin requirements increased moderately.     

Lack of enteral nutrition delays nuclear factor kappa B activation in peritoneal exudative cells in a murine glycogen-induced peritonitis model

Background: Early enteral nutrition is associated with a lower incidence of intraabdominal abscess in severely injured patients than parenteral nutrition (PN). We explored the underlying mechanisms by examining the influence of nutrition route on nuclear factor κB (NFκB) activation in peritoneal exudative cells (PECs) and peritoneal cytokine levels. Methods: Thirty male Institute Cancer Research mice were randomized to chow (n = 10), IV PN (n = 10), or intragastric (IG) PN (n = 10) and fed for 5 days. PECs were harvested at 2 or 4 hours after intraperitoneal injection of 2 mL of 1% glycogen. Intranuclear NFκB activity in PECs was examined by laser scanning cytometry. Cytokine (tumor necrosis factor‐α [TNF‐α], macrophage inflammatory protein‐2 [MIP‐2], interleukin‐10 [IL‐10]) levels in peritoneal lavaged fluid were determined by enzyme‐linked immunosorbent assay. Results: Intranuclear NFκB at 2 hours was significantly higher in the chow and IG‐PN groups than in the IV‐PN group. TNF‐α and IL‐10 levels of the chow group were significantly higher than those of IV‐PN mice at 2 hours, whereas those of IG‐PN mice were midway between those of the chow and IV‐PN groups. MIP‐2 was significantly higher in the chow group than in the IG‐PN and IV‐PN mice at 2 hours. TNF‐α levels correlated positively with intranuclear NFκB activity in PECs. Conclusions: Enteral nutrition may improve peritoneal defense by preserving early NFκB activation in PECs and cytokine responses.     

Enhanced Enteral and Parenteral Nutrition Practice and Outcomes in an Intensive Care Unit with a Hospital-Wide Performance Improvement Process

To improve patient outcomes at a 455-bed community health care facility, a performance improvement process was implemented for the delivery of enteral and parenteral nutrition in a 28-bed intensive care unit (ICU). In 1992, the study group consisted of all patients who were started on either enteral or parenteral nutrition while in the ICU during a 2-month period. These patients were followed up until discharge from the hospital or death to determine practice patterns and outcomes. Three actions were identified as opportunities to change practice and improve outcomes: increase use of the enteral route of alimentation compared with the parenteral route; start alimentation sooner, especially via the enteral route; and meet protein and energy needs of patients. Educational programs were developed targeting physician and nursing staff. Through an interdisciplinary approach, a nutrition support decision tree and patient outcome statement were developed. In 1994, evaluation of a group meeting the same criteria as the original group indicated that the goals for nutrition support practice improvement were met in all three areas identified. Providing a systematic approach to an interdisciplinary performance improvement process, as part of an organization-wide plan, enhanced nutrition support practice in a community hospital and resulted in quality improvement and cost savings. J Am DietAssoc. 1996; 96:484-489.     

ASPEN‐FELANPE Clinical Guidelines

Background: The management of patients with enterocutaneous fistula (ECF) requires an interdisciplinary approach and poses a significant challenge to physicians, wound/stoma care specialists, dietitians, pharmacists, and other nutrition clinicians. Guidelines for optimizing nutrition status in these patients are often vague, based on limited and dated clinical studies, and typically rely on individual institutional or clinician experience. Specific nutrient requirements, appropriate route of feeding, role of immune‐enhancing formulas, and use of somatostatin analogues in the management of patients with ECF are not well defined. The purpose of this clinical guideline is to develop recommendations for the nutrition care of adult patients with ECF. Methods: A systematic review of the best available evidence to answer a series of questions regarding clinical management of adults with ECF was undertaken and evaluated using concepts adopted from the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group. An anonymous consensus process was used to develop the clinical guideline recommendations prior to peer review and approval by the ASPEN Board of Directors and by FELANPE. Questions: In adult patients with enterocutaneous fistula: (1) What factors best describe nutrition status? (2) What is the preferred route of nutrition therapy (oral diet, enteral nutrition, or parenteral nutrition)? (3) What protein and energy intake provide best clinical outcomes? (4) Is fistuloclysis associated with better outcomes than standard care? (5) Are immune‐enhancing formulas associated with better outcomes than standard formulas? (6) Does the use of somatostatin or somatostatin analogue provide better outcomes than standard medical therapy? (7) When is home parenteral nutrition support indicated?     

Comparative pharmacokinetics and pharmacodynamics after subcutaneous and intramuscular administration of medroxyprogesterone acetate (25 mg) and estradiol cypionate (5 mg)

Background

The efficacy of contraceptives is affected by its route and ease of administration. Herein, both pharmacokinetics and pharmacodynamics of the once-a-month combined injectable contraceptive medroxyprogesterone acetate (MPA) plus estradiol cypionate (E₂-Cyp) were compared after intramuscular (IM) or subcutaneous (SC) injection in women of reproductive age.

Study Design

Thirty women were randomly assigned to the SC (n=15) or IM (n=15) route of MPA 25 mg+E₂-Cyp 5 mg administration. Serum samples were obtained daily for 7 days and then three times a week for 40 days in order to quantify E₂, progesterone and MPA. In addition, three ultrasounds were performed on each subject to determine follicular development, and a daily record of the bleeding pattern and side effects was maintained.

Results

A comparative analysis showed that the main pharmacokinetic (peak serum concentration, peak serum time, area under the serum concentration vs. time curve, absorption half-life and elimination half-life) and pharmacodynamic parameters, such as follicular development and ovulation, were similar in the SC vs. IM groups. Complete suppression in ovarian function was present in all women. The bleeding patterns and side effects were similar in both groups.

Conclusions

The results presented herein demonstrate that the injection of 25 mg of MPA plus 5 mg of E₂-Cyp has similar efficacy and safety with either the SC or IM route of administration. The SC option can be considered a viable self-administered contraceptive option that might increase women's compliance to contraceptive use.     

Multitargeted Feeding Strategies Improve Nutrition Outcome and Are Associated With Reduced Pneumonia in a Level 1 Trauma Intensive Care Unit

Background: Factors impeding delivery of adequate enteral nutrition (EN) to trauma patients include delayed EN initiation, frequent surgeries and procedures, and postoperative ileus. We employed 3 feeding strategies to optimize EN delivery: (1) early EN initiation, (2) preoperative no nil per os feeding protocol, and (3) a catch‐up feeding protocol. This study compared nutrition adequacy and clinical outcomes before and after implementation of these feeding strategies. Methods: All trauma patients aged ≥18 years requiring mechanical ventilation for ≥7 days and receiving EN were included. Patients who sustained nonsurvivable injuries, received parenteral nutrition, or were readmitted to the intensive care unit (ICU) were excluded. EN data were collected until patients received an oral diet or were discharged from the ICU. The improvement was quantified by comparing nutrition adequacy and outcomes between April 2014–May 2015 (intervention) and May 2012–June 2013 (baseline). Results: The intervention group (n = 118) received significantly more calories (94% vs 75%, P < .001) and protein (104% vs 74%, P < .001) than the baseline group (n = 121). The percentage of patients receiving EN within 24 and 48 hours of ICU admission increased from 41% to 70% and from 79% to 96% respectively after intervention (P < .001). Although there were fewer 28‐ay ventilator‐free days in the intervention group than in the baseline group (12 vs 16 days, P = .03), receipt of the intervention was associated with a significant reduction in pneumonia (odds ratio, 0.53; 95% confidence interval, 0.31–0.89; P = .017) after adjusting sex and Injury Severity Score. Conclusions: Implementation of multitargeted feeding strategies resulted in a significant increase in nutrition adequacy and a significant reduction in pneumonia.     

Considering Patient Preferences When Selecting Anti–Tumor Necrosis Factor Therapeutic Options

Background

Anti–tumor necrosis factor (TNF) medications for the treatment of chronic inflammatory conditions represent a large and growing expenditure for health plans. Over the past few years, there has been an increase in options for patients receiving anti-TNFs, including choice of agent, route of administration, and location for receiving the medication.

Objective

To examine patient preferences regarding available anti-TNF agents and mode of administration options.

Methods

This cross-sectional survey and claims study was based on administrative claims in the HealthCore Integrated Research Database. Patients were identified for this study if they were receiving infliximab (the intravenous [IV] group) or adalimumab, golimumab, etanercept, or certolizumab pegol (the subcutaneous [SC] group) between March 2012 and August 2012 and were diagnosed with conditions for which these agents are indicated by the US Food and Drug Administration. The survey questionnaire was developed specifically for this study. Participants were asked about their use of anti-TNF agents, locations of administration, preferences for IV or SC therapy, interest in anti-TNF home therapy options, and their physician''s role in their decision-making process. A validated instrument, the Treatment Satisfaction Questionnaire for Medication (TSQM) version II, was used to assess treatment satisfaction by the patients. Results: A total of 6000 patients were included in the final list of patients, and the study was stopped when the targeted number of 500 surveys were completed. The IV group consisted of 202 (40%) patients, and the SC group consisted of 298 (60%) patients. Patients in the SC group had a higher preference for the administration route they were using compared with patients in the IV group: 89.9% of the SC group preferred the SC route of administration, whereas 71.8% of the IV group preferred the IV route (P <.001). The global treatment satisfaction scores were similar in both groups (81.9 in the IV group, 80.1 in the SC group; P = .247). The reported likelihood of patients discussing alternative anti-TNF options with their physician was low (45.5% in the IV group vs 49.7% in the SC group; P = .366).

Conclusions

When asked to make a hypothetical choice between IV and SC administration, patients had stronger preferences for SC routes than for IV routes. There was a strong correlation between the route of administration in use and the preference, indicating high level of satisfaction with the current treatment used, which was confirmed with the TSQM version II results. An opportunity for patient education exists, because conversations with physicians about alternative anti-TNF therapies and administration appear to be lacking.The use of anti-tumor necrosis factor (TNF) medications for the treatment of chronic inflammatory conditions, such as rheumatoid arthritis (RA), Crohn''s disease, or psoriasis, represents a large and growing healthcare expenditure. For example, a 2013 sales forecast for adalimumab, the most frequently used injectable anti-TNF, projected continued growth in annual sales from $9.2 billion to $11.2 billion in 2016,1 and infliximab, an intravenous (IV) infusion anti-TNF, generated more than $7 billion in revenue in 2012.2Parallel with the increased use of the anti-TNFs, there has been emerging evidence that the anti-TNFs have similar effectiveness and safety profiles,3–6 giving patients more options in terms of medication route and frequency of administration. Infliximab, the first anti-TNF approved by the US Food and Drug Administration (FDA),7 is available only as an IV infusion and requires administration by a medical provider every 4 to 8 weeks.8 Patients receiving infliximab have several options regarding where the infusion is administered, all of which include administration by a healthcare professional, including at a medical facility, such as a physician''s office; an infusion center; an outpatient department of a hospital; or at home by a home health agency nurse, all of which are typically covered by insurance plans.

KEY POINTS

• ▸ The anti-TNF agents for chronic inflammatory conditions constitute a large and growing expenditure for health plans.
• ▸ These agents increasingly include more choices, various administration routes, and different service sites for receiving them.
• ▸ Patient preference is integral to the selection of therapeutic agents and routes of administration, which can increase treatment success.
• ▸ For this study, surveys completed by 500 patients discuss their anti-TNF use, preferences for mode of administration, interest in home therapy, and their physician''s role in treatment decisions.
• ▸ A high correlation was seen between current route of administration and patient preference, with 89.9% of patients using SC therapy preferring the SC route and 71.8% of those using IV agents preferring the IV route.
• ▸ Fewer than 50% of respondents discussed alternate anti-TNF options with their physicians, despite their desire for better communication.
• ▸ This study confirms findings of earlier studies but also provides updated information related to alternatives to IV infusions for a large set of indications.

Subcutaneous (SC) anti-TNFs, including etanercept, adalimumab, certolizumab pegol, and golimumab, offer the convenience of self-injection, but they need to be administered on a more frequent schedule, from twice weekly to once monthly, depending on the agent and its FDA indication.9–12 Since the 2013 FDA approval of its IV formulation, golimumab is the only anti-TNF agent available as both SC and IV medications.11In the current healthcare environment of offering a wide variety of treatment options with similar clinical effectiveness but differing routes of administration and dosing regimens, there is an opportunity for patient preferences to play a greater role in the selection of agents. IV treatment may appeal more to patients who desire greater physician control over medication administration, who feel the need for a physician''s presence for a sense of safety, or who have difficulty complying with a self-injecting regimen.13By contrast, despite a more frequent dosing regimen, SC administration offers patients more flexibility and convenience, because their medication can be administered during the time selected by the patient, with no need for medical appointments. Self-administration also eliminates the need to travel to the physician''s office or to other facilities, which usually needs to occur during business hours, thus making it an attractive option for individuals who are more active or who are in the workforce.13Previous research on mode of administration preferences among anti-TNF users is scarce; especially lacking are US-based studies and studies examining a wide variety of indications. A small British study of preferences among 109 patients with RA showed that 48% of patients preferred to administer their medication themselves, whereas 41% preferred having the hospital staff administer the treatment.13A different single-center British study of 100 patients with RA reported that patients receiving anti-TNF therapy and those not yet receiving biologic therapies preferred SC injection as their first choice over intramuscular or IV administration; they also preferred administration at home rather than in an outpatient or inpatient setting.14A 2009 Italian study of 802 patients with RA showed that both IV and SC anti-TNFs were well accepted, with patients evenly split in terms of their preferences for the route of administration.15 Finally, a recent study of 107 patients with RA in Denmark reported that IV administration was preferred by 85% of patients who are currently receiving IV therapies, and SC routes were preferred by 71% of patients who are currently receiving SC therapies.16 We identified only a single US-based study on the topic: a 2008 analysis of 50 patients with irritable bowel disorder reported a slightly greater percentage (54.3%) of patients expressing preference for the SC route of delivery, and all patients who had experienced both routes also preferring SC administration.17Our study was designed to evaluate a large, geographically and clinically diverse, sample of US patients in 2012 who were using anti-TNFs regarding their preferences for route and place of administration, treatment satisfaction, and information sources related to their choice of therapy. This information is especially timely, because there are currently many more anti-TNFs available than before.     

Impact of Early Initiation of Enteral Nutrition on Survival During Pediatric Extracorporeal Membrane Oxygenation

Introduction: Pediatric data related to safety, tolerance, and outcomes of enteral nutrition (EN) for patients requiring extracorporeal membrane oxygenation (ECMO) are lacking. The objectives of this study were to evaluate early nutrition status and timing of EN initiation on survival during pediatric ECMO. Methods: A single center institutional review board–approved retrospective chart review was performed on all pediatric patients requiring ECMO from October 2008 through December 2013. Demographics, ECMO variables, laboratory values, vasoactive inotropic score (VIS), and nutrition data on day 5 (d5) were collected. Patients receiving parenteral nutrition (PN) were compared with those receiving any EN on d5. Analyses were conducted to identify factors influencing survival to completion of ECMO and to discharge. Results: Forty‐nine patients aged 53 ± 76 months met inclusion criteria. Kaplan‐Meier curves demonstrated greater survival to discharge in patients receiving any EN, compared with only receiving PN (P = .031). EN on d5 of ECMO support (P = .040) and a higher percentage of daily energy intake achieved (P = .013) were protective, whereas a higher VIS was associated with increased mortality (P = .010). Multivariable analysis demonstrated EN was no longer associated with survival to discharge (P = .139), whereas energy intake (P = .021) and VIS (P = .013) remained significant. Conclusions: Pediatric patients who received nutrition that was closer to goal energy intake, as well as those who received any EN early during ECMO, had improved survival to hospital discharge.     

A New Intravenous Fat Emulsion Containing Soybean Oil,Medium‐Chain Triglycerides,Olive Oil,and Fish Oil

Background: SMOFlipid 20% is an intravenous lipid emulsion (ILE) containing soybean oil, medium‐chain triglycerides, olive oil, and fish oil developed to provide energy, essential fatty acids (FAs), and long‐chain ω‐3 FAs as a mixed emulsion containing α‐tocopherol. The aim was to assess the efficacy and safety of this new ILE in pediatric patients receiving home parenteral nutrition (HPN) compared with soybean oil emulsion (SOE). Methods: This single‐center, randomized, double‐blind study included 28 children on HPN allocated to receive either SMOFlipid 20% (n = 15) or a standard SOE (Intralipid 20%, n = 13). ILE was administered 4 to 5 times per week (goal dose, 2.0 g/kg/d) within a parenteral nutrition regimen. Assessments, including safety and efficacy parameters, were performed on day 0 and after the last study infusion (day 29). Lipid peroxidation was determined by measurement of thiobarbituric acid reactive substances (TBARS). Results: There were no significant differences in laboratory safety parameters, including liver enzymes, between the groups on day 29. The mean ± standard deviation changes in the total bilirubin concentration between the initial and final values (day 29 to day 0) were significantly different between groups: SMOFlipid group ?1.5 ± 2.4 µmol/L vs SOE group 2.3 ± 3.5 µmol/L, P < .01; 95% confidence interval [CI], ?6.2 to ?1.4). In plasma and red blood cell (RBC) phospholipids, the ω‐3 FAs C20:5ω‐3 (eicosapentaenoic acid) and + C22:6ω‐3 (docosahexaenoic acid) increased significantly in the SMOFlipid group on day 29. The ω‐3:ω‐6 FA ratio was significantly elevated with SMOFlipid 20% compared with SOE group (plasma, day 29: 0.15 ± 0.06 vs 0.07 ± 0.02, P < .01, 95% CI, 0.04–0.11; and RBC, day 29: 0.23 ± 0.07 vs 0.14 ± 0.04, P < .01, 95% CI, 0.04–0.13). Plasma α‐tocopherol concentration increased significantly more with SMOFlipid 20% (15.7 ± 15.9 vs 5.4 ± 15.2 µmol/L, P < .05; 95% CI, ?2.1 to 22.6). The low‐density lipoprotein–TBARS concentrations were not significantly different between both groups, indicating that lipid peroxidation did not differ between groups. Conclusions: SMOFlipid 20%, which contains 15% fish oil, was safe and well tolerated, decreased plasma bilirubin, and increased ω‐3 FA and α‐tocopherol status without changing lipid peroxidation.     

Canadian home parenteral nutrition (HPN) registry: validation and patient outcomes

Background: In Canada, there are an estimated 400 home parenteral nutrition (HPN) patients. In 2006, a registry was created to gather patient outcome information. The aim of this study was to validate the registry and report on HPN patient outcomes. Methods: Several demographic, clinical parameters were collected. For the validation, paired t test and intraclass correlation coefficient (ICC) were used to assess agreement between repeat entries. For the outcome report, paired t test was used to assess changes, and survival analysis was performed using the Kaplan‐Meier method. Results are expressed as mean ± SEM. Results: On validation, there was high correlation/agreement (P < .05) for most parameters except vascular access/line sepsis, liver disease (ultrasound, biopsy, diagnoses), and hospitalizations. For the outcome report, 96 patients had their data entered at 2.24 ± 0.11 years after baseline. Over the period, there was a significant reduction in PN calories (P = .001) and proteins (P < .001). There were no significant changes in nutrition parameters and laboratory results except for lower platelet counts (P = .028), lower plasma potassium (P = .030), and a trend toward an increase in bilirubin from 19.29 ± 4.65 to 29.06 ± 8.73 µmol/L (P = .071). The QOL decreased significantly over time (P < .001) and the survival on HPN was 17.67 ± 1.89 years. Conclusions: The registry is a valid tool to assess several clinical parameters. On follow‐up, HPN patients maintain good nutrition status while PN is reduced but do have a reduced quality of life.     

Tolerability and Safety of Enteral Nutrition in Critically Ill Patients Receiving Intravenous Vasopressor Therapy

Background: Enteral nutrition (EN) is recommended within the first 24–48 hours following admission to an intensive care unit (ICU) once resuscitation and hemodynamic stability have been achieved; however, hemodynamic stability is not well defined. Objective: To evaluate the tolerability and safety of EN in critically ill patients receiving intravenous (IV) vasopressor therapy. Methods: A retrospective medical record review was conducted in an urban academic medical center and included adult ICU patients from 2011 who received concomitant EN and IV vasopressor therapy for ≥1 hour. EN tolerance was defined as an absence of gastric residuals ≥300 mL, emesis, positive finding on abdominal imaging, and evidence of bowel ischemia/perforation. Results: Two hundred fifty‐nine patients received 346 episodes of concomitant EN and IV vasopressor therapy. Overall EN tolerability was 74.9%. Adverse events included rising serum lactate (30.6%), elevated gastric residuals (14.5%), emesis (9.0%), positive finding on kidney/ureter/bladder radiograph (4.3%), and bowel ischemia/perforation (0.9%). An inverse relationship was found between maximum norepinephrine equivalent dose and EN tolerability (12.5 mcg/min for patients who tolerated EN vs 19.4 mcg/min, P = .0009). This relationship remained statistically significant after controlling for other variables (P = .019). Patients who tolerated EN were less likely to have received dopamine (63.8% vs 77.6%, P = .018) or vasopressin (58.9% vs 77.9%, P = .0027). These patients received concomitant therapy for less time and received more nutrition. Conclusions: Most patients receiving IV vasopressor therapy tolerate EN. Tolerability was related to the maximum cumulative vasopressor dose and may be related to the specific vasopressor administered.     

Pediatric Intestinal Failure–Associated Liver Disease Is Reversed With 6 Months of Intravenous Fish Oil

Background: Studies have suggested that when intravenous (IV) soybean oil (SO) is replaced with fish oil (FO), direct hyperbilirubinemia is more likely to resolve. The necessary duration of FO has not been established. This study seeks to determine if 24 weeks of FO is an effective and safe therapy for intestinal failure–associated liver disease (IFALD). Materials and Methods: This is a clinical trial using patients with IFALD between the ages of 2 weeks and 18 years. SO was replaced with FO (1 g/kg/d) in 10 patients who were receiving most of their calories from parenteral nutrition (PN). Patients were compared with 20 historic controls receiving SO. SO for both groups was prescribed by the primary medical team at variable doses. The primary outcome was time to reversal of cholestasis. Secondary outcomes were death, transplant, and full enteral feeds. Safety measurements included growth, essential fatty acid deficiency, and laboratory markers to assess bleeding risk. Results: The Kaplan‐Meier method estimated that 75% in the FO group would experience resolution of cholestasis by 17 weeks vs 6% in the SO group (P < .0001). When compared with the SO group, the FO group had decreased serum direct bilirubin concentrations at weeks 8 (P = .03) and 12, 16, 20, and 24 weeks (P < .0001). Although length z score at the end of the study increased in the FO group compared with baseline (P = .03), there were no significant differences in other outcomes. Conclusions: A limited duration of FO appears to be safe and effective in reversing IFALD.     

Hepatic Indicators of Oxidative Stress and Tissue Damage Accompanied by Systemic Inflammation in Rats Following a 24‐Hour Infusion of an Unstable Lipid Emulsion Admixture

Background: Use of lipid emulsions in parenteral nutrition therapy is an important source of daily energy in substitution of potentially harmful glucose calories when given in excess in the intensive care unit. When added to parenteral nutrition (PN) admixtures as a total nutrient admixture (TNA), the stability and safety of the emulsion may be compromised. Development of a rat model of a stable vs unstable lipid infusion would enable a study of the potential risk. Design: Prospective, randomized, controlled study. Methods: Surgical placement of a jugular venous catheter for the administration of TNAs was performed. Two groups were studied: a stable or s‐TNA (n = 16) and an unstable or u‐TNA (n = 17) as a 24‐hour continuous infusion. Stability of TNAs was determined immediately before and after infusion using a laser‐based method approved by the United States Pharmacopeia. Results: Blood levels of aspartate aminotransferase, glutathione‐S‐transferase, and C‐reactive protein were significantly elevated in u‐TNA vs s‐TNA (P < .05). Also, liver tissue concentrations of malondialdehyde were significantly higher in the u‐TNA group (P < .05), and triglyceride tissue levels were also higher in u‐TNA and approached statistical significance (P = .077). Conclusions: Unstable lipid infusions over 24 hours produce evidence of hepatic accumulation of fat associated with oxidative stress, liver injury, and a low‐level systemic inflammatory response.     

Use of subjective global assessment and clinical outcomes in critically ill geriatric patients receiving nutrition support

The objective of this study is to examine the prevalence of malnutrition and evaluate the nutrition status and clinical outcome in hospitalized patients aged 65 years and older receiving enteral‐parenteral nutrition. This retrospective study was carried out at Ba?kent University Hospital, Adana, Turkey. A total of 119 patients older than 65 years were recruited. Patients were classified into 3 groups: protein‐energy malnutrition (PEM), moderate PEM, and well nourished according to subjective global assessment (SGA) at admission. All patients were fed by enteral or parenteral route. Acute physiological and chronic health evaluation (APACHE‐2) and simplified acute physiology (SAPS 2) scores were recorded in patients followed in the intensive care unit (ICU). Nutrition status was assessed with biochemical (serum albumin, serum prealbumin) parameters. These results were compared with mortality rate and length of hospital stay (LOS). The subjects' mean (±SD) age was 73.1 ± 5.4 years. Using SGA, 5.9% (n = 7) of the patients were classified as severely PEM, 27.7% (n = 33) were classified as moderately PEM, and 66.4% (n = 79) were classified as well nourished. Some 73.1% (n = 87) of the patients were followed in the ICU. Among all patients, 42.9% (n = 51) were fed by a combined enteral‐parenteral route, 31.1% (n = 37) by an enteral route, 18.5% (n = 22) by a parenteral route, and 7.6% (n = 9) by an oral route. The average length of stay for the patients was 18.9 ± 13.7 days. The mortality rate was 44.5% (n = 53). The mortality rate was 43% (n = 34) in well‐nourished patients (n = 79), 48.5% (n = 16) in moderately PEM patients (n = 33), and 42.9% (n = 3) in severely PEM patients (n = 7) (P = .86). The authors observed no difference between well‐nourished and malnourished patients with regard to the serum protein values on admission, LOS, and mortality rate. In this study, malnutrition as defined by SGA did not influence the mortality rate of critically ill geriatric patients receiving enteral or parenteral nutrition. Furthermore, no factor was found to be a good predictor of survival.     

Need for Thiamine in Peripheral Parenteral Nutrition After Abdominal Surgery in Children

Background: Thiamine blood concentrations of pediatric patients receiving peripheral parenteral nutrition change during the postoperative period. In addition, the need to administer thiamine after surgery has not yet been fully studied in children receiving peripheral parenteral nutrition. Objective: The objective of this prospective study is to clarify whether pediatric patients require the administration of thiamine while receiving peripheral parenteral nutrition after abdominal surgery. Patients: Fifteen children were divided into 2 groups; 1 group received peripheral parenteral nutrition without thiamine after surgery (n = 7), whereas the other group received peripheral parenteral nutrition with thiamine after surgery (n = 8). In both groups, thiamine blood concentrations were measured on the preoperative day, and changes in thiamine concentration over time were measured during the starvation period from the first to the fifth postoperative day. Results: Preoperative thiamine blood concentrations were within the normal range in both groups. In the group receiving peripheral parenteral nutrition without thiamine, the thiamine concentration gradually decreased with time after the operation, whereas the concentration remained within the normal range in the group receiving peripheral parenteral nutrition with thiamine. Among the 7 patients receiving peripheral parenteral nutrition without thiamine, the thiamine concentration in 3 patients was below the normal range on the fifth postoperative day. Conclusion: During the starvation period after abdominal surgery, thiamine blood concentrations decreased in pediatric patients receiving peripheral parenteral nutrition without thiamine. Therefore, clinicians treating pediatric patients should add thiamine to the peripheral parenteral nutrition solution during the short starvation period after abdominal surgery.     

Enteral Refeeding Rapidly Restores PN‐Induced Reduction of Hepatic Mononuclear Cell Number Through Recovery of Small Intestine and Portal Vein Blood Flows

Background: Absence of enteral nutrition (EN) reduces hepatic mononuclear cell (MNC) numbers and impairs their functions. However, enteral refeeding (ER) for as little as 12 hours following parenteral nutrition (PN) rapidly restores hepatic MNC numbers. We hypothesized that changes in small intestine and portal vein blood flows related to feeding route might be responsible for this phenomenon. Methods: In experiment 1, mice (n = 19) were randomized to Chow (n = 5), PN (n = 7) or ER (n = 7) groups. The Chow group was given chow ad libitum with intravenous (IV) saline for 5 days. The PN group was fed parenterally for 5 days, while the ER group was re‐fed with chow for 12 hours following 5 days of PN. Then, small intestine and portal vein blood flows were monitored and hepatic MNCs were isolated and counted. In experiment 2, the effects of intravenous administration of prostaglandin E₁ (PGE₁) on hepatic MNC numbers were examined in fasted mice for 12 hours. Mice (n = 28) were randomized to Control (n = 8), PG0 (n = 10), or PG1 (n = 10) groups. The Control group was fed chow ad libitum with IV saline, while the PG0 and PG1 groups were fasted for 12 hours with infusions, respectively, of saline and PGE₁ at 1μ g/kg/minute. Blood flows and hepatic MNC numbers were examined. Results: Experiment 1: ER restored PN‐induced reductions in small intestine and portal vein blood flows and hepatic MNC number to the levels in the Chow group. Small intestine and portal vein blood flows correlated positively with hepatic MNC number. Experiment 2: Fasting decreased small intestine and portal vein blood flows and hepatic MNC number. However, PGE₁ restored portal vein blood flow to the level of the Control group, and moderately increased hepatic MNC number. There was a positive correlation between portal blood flow and hepatic MNC number. Conclusions: Reduced small intestine and portal vein blood flows may contribute to impaired hepatic immunity in the absence of EN. ER quickly restores hepatic MNC number through recovery of blood flow in both the small intestine and the portal vein.