Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis
Information source: Govind Ballabh Pant Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatic Encephalopathy
Intervention: Lactulose (Drug); Lactulose (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Govind Ballabh Pant Hospital Official(s) and/or principal investigator(s): Barjesh C Sharma, MD,DM, Principal Investigator, Affiliation: G B Pant Hospital New Delhi 110002
Overall contact: Barjesh C Sharma, MD,DM, Phone: 9718599203, Email: drbcsharma@hotmail.com
Summary
To assess the effects of lactulose for the prevention of first episode of altered sensorium
(hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.
Clinical Details
Official title: Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis: an Open Labeled Randomized Controlled Trial of Lactulose Versus no Lactulose
Study design: Primary Purpose: Treatment
Primary outcome: prevention of first episode of hepatic encephalopathy
Secondary outcome: Side effects to lactulose and mortality
Detailed description:
Development of hepatic encephalopathy in a patient with cirrhosis is associated with poor
survival rate of 10-70% at one year depending upon hepatic and renal functions. Treating
patients to prevent development of first episode of hepatic encephalopathy is classified as
primary prophylaxis of hepatic encephalopathy and preventing recurrence of hepatic
encephalopathy in patients who had previous episode of hepatic encephalopathy is secondary
prophylaxis of hepatic encephalopathy
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- cirrhotic patients(18-70yrs) who never had encephalopathy
Exclusion Criteria:
- history of taking lactulose in the past 6 weeks
- alcohol intake during the past 6 weeks
- hepatocellular carcinoma
- previous TIPS or shunt surgery
- significant co morbid illness such as heart, respiratory, or renal failure
- neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic
metabolic encephalopathies.
- patients on psychoactive drugs such as antidepressants or sedatives
- who restarted alcohol during follow up
Locations and Contacts
Barjesh C Sharma, MD,DM, Phone: 9718599203, Email: drbcsharma@hotmail.com
G B Pant Hospital, New Delhi, Delhi 110002, India; Recruiting Barjesh C Sharma, MD,DM, Phone: 9718599203, Email: drbcsharma@hotmail.com Praveen Sharma, MD,DM, Phone: 9810365151, Email: drpraveen_sharma@yahoo.com Barjesh C Sharma, MD,DM, Principal Investigator
Additional Information
Starting date: January 2008
Last updated: August 4, 2010
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