Encephalopathy, Hepatic Clinical Trial
Official title:
Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients
Variceal hemorrhage occurs in 25 to 35 % of patients with cirrhosis and accounts for 80 to
90% of bleeding episodes in these patients. Around 25-30 percent of patients develop hepatic
encephalopathy. Development of hepatic encephalopathy in patients with gastrointestinal
bleed can cause increase morbidity with higher hospital costs in these patients. To date no
randomized trial has been done in terms of prevention of encephalopathy in gastrointestinal
hemorrhage. One trial has compared lactulose in combination with antibiotic against mannite,
showed equal efficacy in both groups. No study has been done evaluate the efficacy of
lactulose in prevention of encephalopathy in these patients.
We hypothesize that prophylactic use of Lactulose decreases the risk of development of
hepatic encephalopathy with upper GI bleed in cirrhotics.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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