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Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Govind Ballabh Pant Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT01175538
First received: August 2, 2010
Last updated: August 4, 2010
Last verified: October 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Hepatic Encephalopathy
 Drug: Lactulose
 Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
Drug Information available for: Lactulose
U.S. FDA Resources

Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • prevention of first episode of hepatic encephalopathy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Side effects to lactulose and mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Study Start Date: January 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: lactulose
Drug: Lactulose
lactulose will be used in 30-60ml/day
Other Name: lactulose

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Prof Barjesh Chander Sharma, G B Pant Hospital
ClinicalTrials.gov Identifier: NCT01175538     History of Changes
Other Study ID Numbers: PS001
Study First Received: August 2, 2010
Last Updated: August 4, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Govind Ballabh Pant Hospital:
Hepatic encephalopathy
Lactulose

Additional relevant MeSH terms:
Hepatic Encephalopathy
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
 Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
Lactulose
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013