Constipation Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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