Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT01607060
Status:
COMPLETED
Last Update Posted:
2015-01-07
First Post:
2012-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.
Sponsor:
Federal University of São Paulo
Organization:
Study Overview
Official Title:
Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: