Trial reportCritical care (London, England)2015
Daily laxative therapy reduces organ dysfunction in mechanically ventilated patients: a phase II randomized controlled trial.
Trial report in Critical care (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.
Impact of Naloxegol on Prevention of Lower GI Tract Paralysis in Critically Ill Adults Initiated on Scheduled Intravenous Opioid Therapy: A Randomized, Double-Blind, Placebo-Controlled, Phase II, Single-Center, Proof of Concept Study
Who cites it
10 citing papers in PubMed, 35 citations in OpenAlex.
- Effects of Abdominal Massage for Preventing Acute Postoperative Constipation in Hip Fractures: A Prospective Interventional Study.Clinics in orthopedic surgery · 2023Trial
- Multiple organ dysfunction syndrome: molecular mechanisms and therapeutic strategies.Signal transduction and targeted therapy · 2026Review
- Article
- The Japanese Critical Care Nutrition Guideline 2024.Journal of intensive care · 2025Review
- The Effects of Prophylactic Laxative Use on Critically Ill Patients Requiring Mechanical Ventilation: A Retrospective Cohort Study.Diseases (Basel, Switzerland) · 2024Article
- Epidemiology of constipation in critically ill patients and its impact on in-hospital mortality: a retrospective observational study.Journal of anesthesia · 2022Observational
- Management of gastrointestinal failure in the adult critical care setting.Current opinion in critical care · 2022Review
- Naloxegol to Prevent Constipation in ICU Adults Receiving Opioids: A Randomized Double-Blind Placebo-Controlled Pilot Trial.Critical care research and practice · 2022Article
- Impact of delayed transit in severe COVID 19 critical care patients: A retrospective analysis.Clinics and research in hepatology and gastroenterology · 2021Article
- Efficacy of daiokanzoto in chronic constipation refractory to first-line laxatives.Biomedical reports · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionConstipation is a common problem in intensive care units. We assessed the efficacy and safety of laxative therapy aiming to promote daily defecation in reducing organ dysfunction in mechanically ventilated patients.
methodsWe conducted a prospective, randomized, controlled, nonblinded phase II clinical trial at two general intensive care units. Patients expected to remain ventilated for over 3 days were randomly assigned to daily defecation or control groups. The intervention group received lactulose and enemas to produce 1-2 defecations per day. In the control group, absence of defecation was tolerated up to 5 days. Primary outcome was the change in Sequential Organ Failure Assessment (SOFA) score between the date of enrollment and intensive care unit discharge, death or day 14.
resultsWe included 88 patients. Patients in the treatment group had a higher number of defecations per day (1.3 ± 0.42 versus 0.7 ± 0.56, p < 0.0001) and lower percentage of days without defecation (33.1 ± 15.7% versus 62.3 ± 24.5%, p < 0.0001). Patients in the intervention group had a greater reduction in SOFA score (-4.0 (-6.0 to 0) versus -1.0 (-4.0 to 1.0), p = 0.036) with no difference in mortality rates or in survival time. Adverse events were more frequent in the treatment group (4.5 (3.0-8.0) versus 3.0 (1.0-5.7), p = 0.016), including more days with diarrhea (2.0 (1.0-4.0) versus 1.0 (0-2.0) days, p < 0.0001). Serious adverse events were rare and did not significantly differ between groups.
conclusionsLaxative therapy improved daily defecation in ventilated patients and was associated with a greater reduction in SOFA score.
trial registrationClinical Trials.gov NCT01607060, registered 24 May 2012.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.