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OpenTrials
Completed

NCT Number: NCT01607060

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

São Paulo Hospital

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactulone

Drug

Patients will receive lactulone to daily laxation

Primary outcomes

  1. change in SOFA score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
First posted
May 28, 2012
Registry last updated
Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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