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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

Page last updated: August 23, 2015

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