drugset / Trial / NCT01607060

Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.

NCT01607060 ↗

Phase 3 Completed 88 enrolled Federal University of São Paulo
RandomizedParallel-groupOpen-labelTreatment

Summary

MAIN FEATURES OF THE STUDY: therapeutic intervention. Constipation is a frequent complication in critical ill patients. The disaccharide lactulose has a laxative osmotic activity. Given the scant evidence and the potential risk associated with constipation in seriously ill patients, this study aims to assess the impact of laxative therapy in the prognosis of critically ill patients. Study hypothesis: Constipation is part of the clinical spectrum of intestinal dysfunction and if treated can result in improved prognosis for critically ill patients.

Timeline

Start
2008-09
Primary completion
2012-04
Completion
—

Outcome

Met primary endpoint

paper 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) PMID 26373705 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactulose Other / unclassified 30 ml —

Indications