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Title: The hospital-based evaluation of laxative prophylaxis in ICU (HELP-ICU): A pilot cluster-crossover randomized clinical trial.
Austin Authors: Hay, Tyler;Deane, Adam M;Rechnitzer, Tom;Fetterplace, Kate;Reilly, Rebecca;Ankravs, Melissa;Bailey, Michael;Fazio, Timothy;Anstey, James;D'Costa, Rohit;Presneill, Jeffrey J;MacIsaac, Christopher M;Bellomo, Rinaldo 
Affiliation: Intensive Care
The University of Melbourne, Department of Medicine and Radiology, Parkville, Victoria, Australia
Business Intelligence Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia
Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, Melbourne, Australia
Intensive Care Unit, The Royal Melbourne Hospital, Parkville, Victoria, Australia
The University of Melbourne, Melbourne Medical School, Parkville, Victoria, Australia
The University of Melbourne, Melbourne Medical School, Department of Medicine and Radiology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia
Issue Date: 8-Apr-2019 2019-08
Publication information: Journal of Critical Care 2019; 52: 86-91
Abstract: 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. 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. 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. 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).
DOI: 10.1016/j.jcrc.2019.04.010
ORCID: 0000-0002-1650-8939
Journal: Journal of Critical Care
PubMed URL: 30986760
Type: Journal Article
Subjects: Constipation
Critically ill
Enteral nutrition
Rectal tube
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