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- Title
Daily laxative therapy reduces organ dysfunction in mechanically ventilated patients: a phase II randomized controlled trial.
- Authors
de Azevedo, Rodrigo Palacio; Resende Freitas, Flávio Geraldo; Maria Ferreira, Elaine; de Azevedo, Luciano Cesar Pontes; Ribeiro Machado, Flávia; Freitas, Flávio Geraldo Resende; Ferreira, Elaine Maria; Pontes de Azevedo, Luciano Cesar; Machado, Flávia Ribeiro
- Abstract
<bold>Introduction: </bold>Constipation 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.<bold>Methods: </bold>We 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.<bold>Results: </bold>We 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.<bold>Conclusions: </bold>Laxative therapy improved daily defecation in ventilated patients and was associated with a greater reduction in SOFA score.<bold>Trial Registration: </bold>Clinical Trials.gov NCT01607060, registered 24 May 2012.
- Subjects
MULTIPLE organ failure; ARTIFICIAL respiration; CLINICAL trials; COMPARATIVE studies; CONSTIPATION; CRITICAL care medicine; DEFECATION; DISACCHARIDES; ENEMA; HEALTH status indicators; LENGTH of stay in hospitals; LAXATIVES; RESEARCH methodology; MEDICAL cooperation; RESEARCH; STATISTICAL sampling; EVALUATION research; RANDOMIZED controlled trials; HOSPITAL mortality; PREVENTION; THERAPEUTICS
- Publication
Critical Care, 2015, Vol 19, Issue 1, p1
- ISSN
1364-8535
- Publication type
journal article
- DOI
10.1186/s13054-015-1047-x