Goal-directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload: A randomised,blinded trial (GODIF trial—First version)

Background

Salt and water accumulation leading to fluid overload is associated with increased mortality in intensive care unit (ICU) patients, but diuretics' effects on patient outcomes are uncertain. In this first version of the GODIF trial, we aimed to assess the effects of goal-directed fluid removal with furosemide versus placebo in adult ICU patients with fluid overload.

Methods

We conducted a multicentre, randomised, stratified, parallel-group, blinded, placebo-controlled trial in clinically stable, adult ICU patients with at least 5% fluid overload. Participants were randomised to furosemide versus placebo infusion aiming at achieving neutral cumulative fluid balance as soon as possible. The primary outcome was the number of days alive and out of the hospital at 90 days.

Results

The trial was terminated after the enrolment of 41 of 1000 participants because clinicians had difficulties using cumulative fluid balance as the only estimate of fluid status (32% of participants had their initially registered cumulative fluid balance adjusted and 29% experienced one or more protocol violations). The baseline cumulative fluid balance was 6956 ml in the furosemide group and 6036 ml in the placebo group; on day three, the cumulative fluid balances were 1927 ml and 5139 ml. The median number of days alive and out of hospital at day 90 was 50 days in the furosemide group versus 45 days in the placebo group (mean difference 1 day, 95% CI -19 to 21, p-value .94).

Conclusions

The use of cumulative fluid balance as the only estimate of fluid status appeared too difficult to use in clinical practice. We were unable to provide precise estimates for any outcomes as only 4.1% of the planned sample size was randomised.     

GC/MS-screening analyses of valuable products in the aqueous phase from microwave-assisted hydrothermal processing of Lemna minor

Microwave-assisted hydrothermal treatment of Lemna minor plant material was studied under subcritical conditions. The water phases of this process were extracted with polar and nonpolar solvents and the extracts were investigated by GC/MS screening analyses for value added products. The polar extracts were dominated by compounds known as flavouring agents and partly as platform chemicals, e.g. hydroxyacetone, 1-hydroxybutan-2-one, furfural, cyclotene and pyrrolidone. Pyridinol, an important educt for heterocyclic chemistry, was another interesting product. Benzaldehyde and oleamide were detected as main products in nonpolar n-hexane extracts. An essential aspect is that a large proportion of compounds like aldehyds and ketones were obtained when mild hydrothermal processing was applied.     

Influence of impression material and time on the 3-dimensional accuracy of implant impressions.

OBJECTIVE: To investigate, in vitro, the effect of time on the 3-dimensional accuracy of open-tray implant impression copings made of polyvinyl siloxane and polyether impression materials. METHOD AND MATERIALS: Reference models with 4 internal connection implants were fabricated. Four sets of 71 direct impressions were made with square impression copings using an open-tray technique. One set of impressions was made with polyether material (material A) and each of 3 polyvinyl siloxane materials (materials B, C, and D). Three-dimensional changes in spatial orientation of the implant analogs were measured over 48 hours using an optical measurement device. Deviation values were summed over 4 points and averaged per impression. Global differences were tested with a nonparametric Kruskal-Wallis test followed by pairwise comparisons using the Mann-Whitney U test. RESULTS: The mean dimensional accuracy of implant impressions significantly differed over time (P < .001). Materials A and B were found to produce comparable results, For materials C and D there was a significant increase in deviations, with a maximum increase at 2 hours. Deviations for material C were comparable to materials A and B at 48 hours. Baseline values were not maintained by any material. CONCLUSIONS: Within the limits of this in vitro study, it can be concluded that time cannot be neglected as a factor affecting the accuracy of implant master casts.     

Zinc gluconate in the treatment of dysgeusia--a randomized clinical trial

In the treatment of dysgeusia, the use of zinc has been frequently tried, with equivocal results. The aim of the present randomized clinical trial, which involved a sufficiently large sample, was therefore to determine the efficacy of zinc treatment. Fifty patients with idiopathic dysgeusia were carefully selected. Zinc gluconate (140 mg/day; n=26) or placebo (lactose; n=24) was randomly assigned to the patients. The patients on zinc improved in terms of gustatory function (p <0.001) and rated the dysgeusia as being less severe (p <0.05). Similarly, signs of depression in the zinc group were less severe (Beck Depression Inventory, p <0.05; mood scale, p <0.05). With the exception of the salivary calcium level, which was higher in the zinc patients (p <0.05), no other significant group differences were found. In conclusion, zinc appears to improve general gustatory function and, consequently, general mood scores in dysgeusia patients.     

Comparative studies on the bacteriostatic effect of "Grisaldon" and "Cholinesalicylate gel"]

The authors present a choline salicylate gel at present on trial and compare it, by means of microbiologic studies, with Grisaldon as to composition, consistency and bacteriostatic properties. Choline salicylate showed a good bacteriostatic effect. As to Grisaldon, the conditions are considerably less favorable due to the poor solubility of acetylsalicylic acid.     

Dental anxiety--an epidemiological study on its clinical correlation and effects on oral health

Pronounced dental anxiety could lead to avoidance strategies to evade dental visits. The aim of the present epidemiological study was to investigate the prevalence and related oral disease patterns of dental anxiety in young adult male soldiers. Therefore, the intensity and frequency of dental anxiety are presented and the correlation with oral clinical findings are evaluated. Three hundred seventy-four soldiers who underwent a compulsory dental check-up were randomly assigned to this study. Psychological parameters were collected based on a protocol integrating the Dental Anxiety Scale (DAS) and the Gatchell Fear Scale (GaFS). Patient-based measures included D3,4MF-scores for dental status and the Community Periodontal Index of Treatment Need (CPITN) for periodontal status. Thirty-two individuals (8.6%) showed DAS-scores of 13 or 14 (anxious), while 4.6% had a DAS-score > or = 15 (highly anxious/phobic). Highest DAS-values were measured among patients' aged 19-29 (n = 262). DMFS-values of anxious and less anxious patients showed only minor differences. However, anxious patients had significantly more carious lesions (P < 0.001). CPITN periodontal values showed no significant differences between both groups. 89.2% of less anxious individuals and 79.6% of anxious patients went for regular dental check-ups. Thus, every tenth patient was considered to have high dental anxiety. Anxiety results in avoidance behaviour, which can only be discovered upon compulsory examinations and which is associated with higher caries morbidity and need for oral rehabilitation. As anxiety has a direct influence on oral health, it should be detected and accounted for in a treatment concept integrating dental and cognitive-behavioural therapeutic approaches.     

Laparoscopic gastro-jejunal anastomosis using novel r2 deflectable instruments in an ex vivo model

Objective A novel 5?mm steerable instrument system (r2-DRIVE) was developed with active tip deflection and tip and shaft rotation. The feasibility and training effect of the r2 instruments were determined in a phantom model. Material and methods Experienced laparoscopic surgeons and untrained novices performed laparoscopic gastro-jejunal anastomoses using porcine tissue and r2 DRIVE-instruments. Mean anastomosis time, anastomosis width and burst pressure were measured. Number of stitches, skipped stitches and dropped needles were counted. Results of trained and untrained subjects were compared. Results Mean time for suturing decreased rapidly for all participants, but was more evident for untrained persons. After five anastomoses no relevant improvement in anastomotic time was seen for the skilled group. The ease of use, efficacy of manipulation and swift training effect with the novel r2 instruments for both experienced laparoscopic surgeons and untrained non-surgeons could be demonstrated and after few cases stable anastomosis times and a fast learning curve were obtained. Conclusions This study demonstrates the ease of use, efficacy of manipulation and swift training effect with the novel r2 instruments for both experienced laparoscopic surgeons and untrained non-surgeons. After few cases stable anastomosis times and a fast learning curve were obtained.     

Chronic Hepatitis E in Heart Transplant Recipients

Chronic courses of hepatitis E virus (HEV) infections have been described in immunosuppressed patients. We aimed to study the role of HEV infections in heart transplant recipients (HTR). 274 HTR were prospectively screened for HEV infection using an anti‐HEV‐IgG ELISA and HEV‐PCR. In addition, 137 patients undergoing cardiac surgery (non‐HTR) and 537 healthy subjects were studied cross‐sectionally. The anti‐HEV‐IgG seroprevalence was 11% in HTR, 7% in non‐HTR and 2% in healthy controls (HTR vs. healthy controls p<0.0001; non‐HTR vs. healthy controls p<0.01). Anti‐HEV tested positive in 4.0% in control cohorts of other immunocompromised patients (n = 474). Four HTR (1.5%) were chronically infected with HEV as shown by HEV‐PCR and all four patients had liver transaminases of >200 IU/L and histological or clinical evidence of advanced liver disease. In three patients ribavirin treatment was successful with a sustained biochemical and virological response while treatment failed in one cirrhotic patient after ribavirin dose reduction. Heart transplant recipients and patients undergoing cardiac surgery have an increased risk for HEV infections. Chronic hepatitis E may explain elevated liver enzymes in heart transplant recipients. Treatment of HEV infection with ribavirin is effective but the optimal dose and duration of ribavirin therapy remains to be determined.     

Clinical use of a novel audio pillow with recorded hypnotherapy instructions and music for anxiolysis during dental implant surgery: a prospective study

A prospective, comparative study of a novel audio pillow with hypnosis text and relaxation music was conducted in 82 dental-implant surgery patients to relieve anxiety over a 6-month period. Visual analogue scales combined with the Aachen Dental Treatment Fear Inventory (AZI) questionnaire were used to quantify patients' subjective feelings of fear. Blood pressure, heart rate, and capillary oxygen partial pressure were measured before, during, and after surgery. The AZI scores decreased in the hypnotherapy group (n = 44) and increased slightly in the control group; scores were significantly different between the groups (p = .000). During surgery, the average diastolic blood pressure and heart rate decreased in the hypnotherapy group and increased in controls. Thus, this audio pillow with relaxation music showed anxiolytic effects in patients during dental implantation procedures.