Feasibility of Embedding a Randomised Clinical Trial (RCT) into an Electronic Medical Record (EMR) for Patients Admitted to an Intensive Care Unit (ICU).

To establish the feasibility of embedding an RCT into EMR in the ICU, we evaluated the route of phosphate replacement. The EMR screened 207 patients who met the inclusion criteria from 20 April 2022 to 30 June 2022. 162 patients were randomised and 145 patients allocated to treatment. Our study showed that it was feasible to embed screening, randomisation, and treatment allocation for an RCT within an EMR in the ICU.

The hospital-based evaluation of laxative prophylaxis in ICU (HELP-ICU): A pilot cluster-crossover randomized clinical trial.

PURPOSE: Prophylactic laxative regimens may prevent constipation but may increase diarrhea and subsequent rectal tube insertion. Our aim was to compare three prophylactic laxative regimens on the rate of rectal tube insertion (primary outcome) and major constipation- or diarrhea-associated complications. MATERIAL AND METHODS: We conducted a cluster-crossover trial. Three pods in a single ICU were each randomized to one of three regimens for four months with rolling cross-over. All mechanically-ventilated and enterally-fed adult patients received either regimen: A) one coloxyl with senna BD from day one; B) two coloxyl with senna +20 ml lactulose BD commencing on day 3; or C) two coloxyl with senna tablets +20 ml lactulose BD commencing on day 6. RESULTS: We enrolled 570 patients (A = 170, B = 205, C = 195) with similar baseline features. Overall, 53 (9.3%) patients received a rectal tube, and insertion rate was not statistically different between the three regimens (A = 12.9%, B = 7.8%, C = 7.7%; p = 0.15). The proportions of patients with other major constipation- or diarrhea-associated complications were similar, as were major patient-centred outcomes. CONCLUSION: Earlier commencement of a prophylactic coloxyl-based laxative regimen (day 1 or 3) did not affect the rates of complications associated with constipation or diarrhea when compared to delayed introduction (day 6).

Constipation, diarrhea, and prophylactic laxative bowel regimens in the critically ill: A systematic review and meta-analysis.

INTRODUCTION: Prophylactic laxative bowel regimens may prevent constipation in enterally-fed critically ill patients. However, their use may also increase diarrhea. We performed a systematic review to: 1. Explore the epidemiology of constipation and/or diarrhea in critically ill patients; and 2. Appraise trials evaluating prophylactic laxative bowel regimens. METHODS: We searched MEDLINE, Embase, and CINAHL for publications that reported constipation or diarrhea in critically ill adult patients and/or prophylactic laxative bowel regimens. RESULTS: The proportion of critically ill patients experiencing constipation was reported between 20% and 83% and the proportion experiencing diarrhea was reported between 3.3% and 78%. Six studies of prophylactic laxative bowel regimens were identified but only 3 randomised controlled trials were identified, and these were subjected to meta-analysis. Compared with placebo, a prophylactic laxative bowel regimen increased the risk of diarrhea (RR 1.58, 95% CI 1.22 to 2.04) but did not reduce the risk of constipation (RR 0.39, 95% CI 0.14 to 1.05), and did not affect the duration of mechanical ventilation, duration of ICU admission, or mortality. CONCLUSIONS: Constipation and diarrhea occur frequently in the critically ill but data evaluating prophylactic laxative bowel regimens in such patients are sparse and do not support their use.