Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-09-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Hepatic Encephalopathy

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Lactulose

Group Type EXPERIMENTAL

Lactulose

Intervention Type DRUG

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

Intervention Type DRUG

lactulose will be used in 30-60ml/day

Interventions

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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

Intervention Type DRUG

Lactulose

lactulose will be used in 30-60ml/day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No