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

Primary Purpose

Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy, Encephalopathy, Hepatic

Status
Unknown status
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Lactulose
Placebo
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocerebral Encephalopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aga Khan university
  • Aga Khan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Lactulose 30 ml q6h for 48 hrs

Placebo 30 ml q6 hrly for 48hrs

Outcomes

Primary Outcome Measures

Development of Clinically Overt Hepatic Encephalopathy

Secondary Outcome Measures

Death, hospital stay

Full Information

First Posted
November 2, 2007
Last Updated
November 2, 2007
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT00553423
Brief Title
Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
Official Title
Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy, Encephalopathy, Hepatic, Encephalopathy, Hepatocerebral

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Lactulose 30 ml q6h for 48 hrs
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo 30 ml q6 hrly for 48hrs
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
Lactulose 30 ml q6h for 48 hrs
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 30 ml q6hrly for 48 hrs
Primary Outcome Measure Information:
Title
Development of Clinically Overt Hepatic Encephalopathy
Time Frame
48hours
Secondary Outcome Measure Information:
Title
Death, hospital stay
Time Frame
48hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahid Majid, FCPS
Phone
9221-4930051
Ext
4447
Email
shahid.majid@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Salih, FCPS
Phone
9221-4930051
Ext
4528
Email
mohammad.salih@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahid Majid, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Salih, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shahid Ahmed, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wasim Jafri, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Study Chair
Facility Information:
Facility Name
Aga Khan university
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahid Majid, FCPS
Phone
9221-4930051
Ext
4447
Email
shahid.majid@aku.edu
First Name & Middle Initial & Last Name & Degree
Mohammad Salih, FCPS
Phone
9221-4930051
Ext
4528
Email
mohammad.salih@aku.edu
First Name & Middle Initial & Last Name & Degree
Shahid Majid, FCPS
First Name & Middle Initial & Last Name & Degree
Mohammad Salih, FCPS
First Name & Middle Initial & Last Name & Degree
Shahid Ahmed, FCPS
First Name & Middle Initial & Last Name & Degree
Wasim Jafri, FRCP, FACG
Facility Name
Aga Khan University
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahid Majid, FCPS
Phone
9221-4930051
Ext
4447
Email
shahid.majid@aku.edu
First Name & Middle Initial & Last Name & Degree
Mohammad Salih, FCPS
Phone
9221-4930051
Ext
4528
Email
mohammad.salih@aku.edu

12. IPD Sharing Statement

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

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