Hepatic Encephalopathy
Conditions
Keywords
Hepatic encephalopathy, Lactulose
Brief summary
To assess the effects of lactulose for the prevention of first episode of altered sensorium (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.
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
Interventions
DRUGLactulose
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
Sponsors
Govind Ballabh Pant Hospital
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prevention of first episode of hepatic encephalopathy | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Side effects to lactulose and mortality | 6 months |
Countries
India
Contacts
Primary ContactBarjesh C Sharma, MD,DM
Outcome results
None listed