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

November 2, 2007 updated by: Aga Khan University

Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sind
      • Karachi, Sind, Pakistan, 74800
        • Not yet recruiting
        • Aga Khan University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shahid Majid, FCPS
        • Sub-Investigator:
          • Mohammad Salih, FCPS
        • Sub-Investigator:
          • Shahid Ahmed, FCPS
        • Sub-Investigator:
          • Wasim Jafri, FRCP, FACG
      • Karachi, Sind, Pakistan, 74800
        • Recruiting
        • Aga Khan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of Clinically Overt Hepatic Encephalopathy
Time Frame: 48hours
48hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Death, hospital stay
Time Frame: 48hrs
48hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Study Completion (ANTICIPATED)

November 1, 2008

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (ESTIMATE)

November 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 4, 2007

Last Update Submitted That Met QC Criteria

November 2, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06GS013MED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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