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

NCT ID: NCT01607060

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lactulone

Patients receiving lactulone

Group Type: EXPERIMENTAL

Lactulone

Intervention Type: DRUG

Patients will receive lactulone to daily laxation

Control

Observational group. Compare to lactulone group.

Group Type: ACTIVE_COMPARATOR

Lactulone

Intervention Type: DRUG

Patients will receive lactulone to daily laxation

Interventions

Lactulone

Patients will receive lactulone to daily laxation

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Palácio de Azevedo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

São Paulo Hospital

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 26373705 (View on PubMed)

Other Identifiers

Lactulona

Identifier Type: -

Identifier Source: org_study_id