Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

August 4, 2010 updated by: Govind Ballabh Pant Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lactulose
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
Drug: Lactulose
lactulose will be used in 30-60ml/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevention of first episode of hepatic encephalopathy
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects to lactulose and mortality
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Govind Ballabh Pant Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ANTICIPATED)

June 1, 2010

Study Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (ESTIMATE)

August 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2010

Last Update Submitted That Met QC Criteria

August 4, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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