Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.
1 other identifier
interventional
88
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
May 28, 2012
CompletedJanuary 7, 2015
October 1, 2012
3.6 years
May 24, 2012
January 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Lactulone
EXPERIMENTALPatients receiving lactulone
Control
ACTIVE COMPARATORObservational group. Compare to lactulone group.
Interventions
Eligibility Criteria
You may qualify if:
- ICU patients expected to stay for 3 more days, on mechanical ventilation and receiving at least 20% of calculated nutrient intake enterally.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
São Paulo Hospital
São Paulo, São Paulo, Brazil
Related Publications (1)
de Azevedo RP, Freitas FG, Ferreira EM, Pontes de Azevedo LC, Machado FR. Daily laxative therapy reduces organ dysfunction in mechanically ventilated patients: a phase II randomized controlled trial. Crit Care. 2015 Sep 16;19(1):329. doi: 10.1186/s13054-015-1047-x.
PMID: 26373705DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 24, 2012
First Posted
May 28, 2012
Study Start
September 1, 2008
Primary Completion
April 1, 2012
Last Updated
January 7, 2015
Record last verified: 2012-10