Constipation Clinical Trial
Official title:
Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.
NCT number | NCT01607060 |
Other study ID # | Lactulona |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | May 24, 2012 |
Last updated | January 5, 2015 |
Start date | September 2008 |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - ICU patients expected to stay for 3 more days, on mechanical ventilation and receiving at least 20% of calculated nutrient intake enterally. Exclusion Criteria: - younger than 18 years, - pregnancy, - contraindication to enteral nutrition, - patients with liver disease, - contraindications to the use of lactulose, - patients with poor prognosis or without full therapeutic indication investment, - presence of colostomy or ileostomy, - intestinal diseases, - such as disease Crohn's, - ulcerative colitis, - short bowel syndrome. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | São Paulo Hospital | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in SOFA score | Will evaluate the change in SOFA score between the time of enrollment and 14 days after enrollment, or discharge, or death if it occurs before that date. | At the moment of inclusion and 14 days latter | No |
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