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NCT01175538 Clinical Trial

Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

Hepatic Encephalopathy Clinical Trial

Official title:
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis: an Open Labeled Randomized Controlled Trial of Lactulose Versus no Lactulose

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01175538
Other study ID # PS001
Secondary ID
Status Recruiting
Phase Phase 4
First received August 2, 2010
Last updated August 4, 2010
Start date January 2008
Est. completion date September 2010

Study information
Verified date October 2009
Source Govind Ballabh Pant Hospital
Contact Barjesh C Sharma, MD,DM
Phone 9718599203
Email drbcsharma@hotmail.com
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To assess the effects of lactulose for the prevention of first episode of altered sensorium (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date September 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lactulose
In the Gp-L group, patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day
• Lactulose
lactulose will be used in 30-60ml/day

Locations
Country Name City State
India G B Pant Hospital New Delhi Delhi

Sponsors (1)
Lead Sponsor Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevention of first episode of hepatic encephalopathy 6 months Yes
Secondary Side effects to lactulose and mortality 6 months Yes
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