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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

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

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

NCT ID

NCT00553423

First Posted

November 2, 2007

Last Updated

November 2, 2007

Sponsor

Aga Khan University

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

Arm Type

Experimental

Arm Description

Lactulose 30 ml q6h for 48 hrs

Arm Title

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

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

shahid.majid@aku.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammad Salih, FCPS

Phone

9221-4930051

Ext

4528

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

shahid.majid@aku.edu

First Name & Middle Initial & Last Name & Degree

Mohammad Salih, FCPS

Phone

9221-4930051

Ext

4528

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

shahid.majid@aku.edu

First Name & Middle Initial & Last Name & Degree

Mohammad Salih, FCPS

Phone

9221-4930051

Ext

4528

mohammad.salih@aku.edu

12. IPD Sharing Statement

Learn more about this trial

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

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