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

Phase 3

Completed

• Conditions: Constipation
• Interventions: Drug: Lactulone

• Registration Number: NCT01607060
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

OBJECTIVES: Evaluate the impact of daily laxative therapy in the prognosis of critically ill patients through the evaluation of organ failure by the sequential organ failure score assessment (SOFA). Will also be evaluated morbidity data, namely incidence of bloodstream infection, pneumonia and severe sepsis, days free of mechanical ventilation, length of hospital stay, ICU and hospital mortality.

The study will be conducted in two intensive care units of Hospital Sao Paulo, UNIFESP. Inclusion criteria: patients who are mechanically ventilated, with prediction to stay in the ICU for more than three days and getting at least 20% of full nutritional support in the form of enteral nutrition. Patients will be randomized into two groups: Group 1 - patients treated according to medical prescription. Group 2 - patients will receive lactulone in order to evacuate daily. The patient included in the intervention group will receive latulose 30 ml of 8 in 8 hours. Patients will be monitored, adjusted doses and procedures, if necessary. It is intended to include 44 patients per group.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2012-04
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Status Verified: 2012-10
• Last Update Submitted: 2015-01-05
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Lactulone	Observational group. Compare to lactulone group.
Lactulone	Lactulone	Patients receiving lactulone

Primary Outcome Measures

Name	Time	Method
change in SOFA score	At the moment of inclusion and 14 days latter	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.

Trial Locations

Locations (1)

São Paulo Hospital; 🇧🇷 São Paulo, Brazil