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

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ClinicalTrials.gov Identifier: NCT01607060
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : January 7, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Constipation Drug: Lactulone Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.
Study Start Date : September 2008
Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Lactulose
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lactulone
Patients receiving lactulone
Drug: Lactulone
Patients will receive lactulone to daily laxation
Active Comparator: Control
Observational group. Compare to lactulone group.
Drug: Lactulone
Patients will receive lactulone to daily laxation

Outcome Measures

Primary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607060

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rodrigo Palácio de Azevedo, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01607060     History of Changes
Other Study ID Numbers: Lactulona
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: October 2012

Keywords provided by Rodrigo Palácio de Azevedo, Federal University of São Paulo:
Critically ill patients
intestinal failure

Additional relevant MeSH terms:
Critical Illness
Signs and Symptoms, Digestive
Signs and Symptoms
Disease Attributes
Pathologic Processes
Gastrointestinal Agents