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Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Aga Khan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00553423
First received: November 2, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients


Condition Intervention Phase
Hepatocerebral Encephalopathy
Portal-Systemic Encephalopathy
Encephalopathy, Hepatic
Encephalopathy, Hepatocerebral
 Drug: Lactulose
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage

Resource links provided by NLM:

Drug Information available for: Lactulose
U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Development of Clinically Overt Hepatic Encephalopathy [ Time Frame: 48hours ]

Secondary Outcome Measures:
  • Death, hospital stay [ Time Frame: 48hrs ]

Estimated Enrollment: 128
Study Start Date: November 2007
Estimated Study Completion Date: November 2008
Arms Assigned Interventions
Experimental: 1
Lactulose 30 ml q6h for 48 hrs
 Drug: Lactulose
Lactulose 30 ml q6h for 48 hrs
Placebo Comparator: 2
Placebo 30 ml q6 hrly for 48hrs
 Drug: Placebo
Placebo 30 ml q6hrly for 48 hrs

Detailed Description:

Variceal hemorrhage occurs in 25 to 35 % of patients with cirrhosis and accounts for 80 to 90% of bleeding episodes in these patients. Around 25-30 percent of patients develop hepatic encephalopathy. Development of hepatic encephalopathy in patients with gastrointestinal bleed can cause increase morbidity with higher hospital costs in these patients. To date no randomized trial has been done in terms of prevention of encephalopathy in gastrointestinal hemorrhage. One trial has compared lactulose in combination with antibiotic against mannite, showed equal efficacy in both groups. No study has been done evaluate the efficacy of lactulose in prevention of encephalopathy in these patients.

We hypothesize that prophylactic use of Lactulose decreases the risk of development of hepatic encephalopathy with upper GI bleed in cirrhotics.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in ER

Exclusion Criteria:

  • Increased α-fetoprotein level/ Documented hepatoma
  • Portal or hepatic vein thrombosis
  • Large-volume or tense ascites requiring repeated therapeutic paracentesis
  • Serious recurrent or ongoing co morbid illness (e.g., severe renal, cardiac, or respiratory failure; sepsis)
  • Pregnancy
  • Not willing to give consent to participate in the study
  • Patients who are unable to read and write
  • ER arrival time > 12 hrs from index bleed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553423

Contacts
Contact: Shahid Majid, FCPS 9221-4930051 ext 4447 shahid.majid@aku.edu
Contact: Mohammad Salih, FCPS 9221-4930051 ext 4528 mohammad.salih@aku.edu

Locations
Pakistan
Aga Khan university Not yet recruiting
Karachi, Sind, Pakistan, 74800
Contact: Shahid Majid, FCPS     9221-4930051 ext 4447     shahid.majid@aku.edu    
Contact: Mohammad Salih, FCPS     9221-4930051 ext 4528     mohammad.salih@aku.edu    
Principal Investigator: Shahid Majid, FCPS            
Sub-Investigator: Mohammad Salih, FCPS            
Sub-Investigator: Shahid Ahmed, FCPS            
Sub-Investigator: Wasim Jafri, FRCP, FACG            
Aga Khan University Recruiting
Karachi, Sind, Pakistan, 74800
Contact: Shahid Majid, FCPS     9221-4930051 ext 4447     shahid.majid@aku.edu    
Contact: Mohammad Salih, FCPS     9221-4930051 ext 4528     mohammad.salih@aku.edu    
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Shahid Majid, FCPS Aga Khan University
Study Director: Mohammad Salih, FCPS Aga Khan University
Study Director: Shahid Ahmed, FCPS Aga Khan University
Study Chair: Wasim Jafri, FCPS Aga Khan University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00553423     History of Changes
Other Study ID Numbers: 06GS013MED
Study First Received: November 2, 2007
Last Updated: November 2, 2007
Health Authority: Pakistan: Research Ethics Committee

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Brain Diseases, Metabolic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
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

ClinicalTrials.gov processed this record on May 21, 2013