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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rodrigo Palácio de Azevedo, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01607060
First received: May 24, 2012
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Constipation
Drug: Lactulone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • change in SOFA score [ Time Frame: At the moment of inclusion and 14 days latter ] [ Designated as safety issue: No ]
    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.


Enrollment: 88
Study Start Date: May 2009
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactulone
Patients receiving lactulone
Drug: Lactulone
Patients will receive lactulone to daily laxation
Other Name: Lactulone
Active Comparator: Control
Observational group. Compare to lactulone group.
Drug: Lactulone
Patients will receive lactulone to daily laxation
Other Name: Lactulone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607060

Locations
Brazil
São Paulo Hospital
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Rodrigo Palácio de Azevedo, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01607060     History of Changes
Other Study ID Numbers: Lactulona
Study First Received: May 24, 2012
Last Updated: October 1, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Critically ill patients
intestinal failure

Additional relevant MeSH terms:
Constipation
Critical Illness
Disease Attributes
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Laxatives
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014