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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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Aga Khan University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553423
First Posted: November 5, 2007
Last Update Posted: November 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aga Khan University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

ClinicalTrials.gov Identifier: NCT00553423     History of Changes
Other Study ID Numbers: 06GS013MED
First Submitted: November 2, 2007
First Posted: November 5, 2007
Last Update Posted: November 5, 2007
Last Verified: October 2007

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