Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis
Primary Purpose
Hepatic Encephalopathy
Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Lactulose
Lactulose
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Hepatic encephalopathy, Lactulose
Eligibility 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
Sites / Locations
- G B Pant HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lactulose
Arm Description
Outcomes
Primary Outcome Measures
prevention of first episode of hepatic encephalopathy
Secondary Outcome Measures
Side effects to lactulose and mortality
Full Information
NCT ID
NCT01175538
First Posted
August 2, 2010
Last Updated
August 4, 2010
Sponsor
Govind Ballabh Pant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01175538
Brief Title
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis
Official Title
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis: an Open Labeled Randomized Controlled Trial of Lactulose Versus no Lactulose
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Govind Ballabh Pant Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Hepatic encephalopathy, Lactulose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Arm Title
Lactulose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
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
Intervention Name(s)
Lactulose
Intervention Description
lactulose will be used in 30-60ml/day
Primary Outcome Measure Information:
Title
prevention of first episode of hepatic encephalopathy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Side effects to lactulose and mortality
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barjesh C Sharma, MD,DM
Phone
9718599203
Email
drbcsharma@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barjesh C Sharma, MD,DM
Organizational Affiliation
G B Pant Hospital New Delhi 110002
Official's Role
Principal Investigator
Facility Information:
Facility Name
G B Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barjesh C Sharma, MD,DM
Phone
9718599203
Email
drbcsharma@hotmail.com
First Name & Middle Initial & Last Name & Degree
Praveen Sharma, MD,DM
Phone
9810365151
Email
drpraveen_sharma@yahoo.com
First Name & Middle Initial & Last Name & Degree
Barjesh C Sharma, MD,DM
12. IPD Sharing Statement
Learn more about this trial
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis
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