Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.
NCT01607060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2015-01-07
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.
Conditions
Interventions
- DRUG
-
Lactulone
Patients will receive lactulone to daily laxation
Sponsors & Collaborators
-
Federal University of São Paulo
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2012-04-30
Countries
- Brazil
Study Locations
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