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Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

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ClinicalTrials.gov Identifier: NCT01175538
Recruitment Status : Unknown
Verified October 2009 by Govind Ballabh Pant Hospital.
Recruitment status was:  Recruiting
First Posted : August 5, 2010
Last Update Posted : August 5, 2010
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital

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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: Lactulose Phase 4

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  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis: an Open Labeled Randomized Controlled Trial of Lactulose Versus no Lactulose
Study Start Date : January 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : September 2010


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




Primary Outcome Measures :
  1. prevention of first episode of hepatic encephalopathy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Side effects to lactulose and mortality [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175538


Contacts
Contact: Barjesh C Sharma, MD,DM 9718599203 drbcsharma@hotmail.com

Locations
India
G B Pant Hospital Recruiting
New Delhi, Delhi, India, 110002
Contact: Barjesh C Sharma, MD,DM    9718599203    drbcsharma@hotmail.com   
Contact: Praveen Sharma, MD,DM    9810365151    drpraveen_sharma@yahoo.com   
Principal Investigator: Barjesh C Sharma, MD,DM         
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
Principal Investigator: Barjesh C Sharma, MD,DM G B Pant Hospital New Delhi 110002

Responsible Party: Prof Barjesh Chander Sharma, G B Pant Hospital
ClinicalTrials.gov Identifier: NCT01175538     History of Changes
Other Study ID Numbers: PS001
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: August 5, 2010
Last Verified: October 2009

Keywords provided by Govind Ballabh Pant Hospital:
Hepatic encephalopathy
Lactulose

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Lactulose
Gastrointestinal Agents