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

NCT ID: NCT00553423

Last Updated: 2007-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Hepatocerebral Encephalopathy Portal-Systemic Encephalopathy Encephalopathy, Hepatic Encephalopathy, Hepatocerebral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Lactulose 30 ml q6h for 48 hrs

Group Type EXPERIMENTAL

Lactulose

Intervention Type DRUG

Lactulose 30 ml q6h for 48 hrs

2

Placebo 30 ml q6 hrly for 48hrs

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 30 ml q6hrly for 48 hrs

Interventions

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Lactulose

Lactulose 30 ml q6h for 48 hrs

Intervention Type DRUG

Placebo

Placebo 30 ml q6hrly for 48 hrs

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Principal Investigators

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Shahid Majid, FCPS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Mohammad Salih, FCPS

Role: STUDY_DIRECTOR

Aga Khan University

Shahid Ahmed, FCPS

Role: STUDY_DIRECTOR

Aga Khan University

Wasim Jafri, FCPS

Role: STUDY_CHAIR

Aga Khan University

Locations

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Aga Khan university

Karachi, Sindh, Pakistan

Site Status NOT_YET_RECRUITING

Aga Khan University

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Shahid Majid, FCPS

Role: CONTACT

Phone: 9221-4930051

Email: [email protected]

Mohammad Salih, FCPS

Role: CONTACT

Phone: 9221-4930051

Email: [email protected]

Facility Contacts

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Shahid Majid, FCPS

Role: primary

Mohammad Salih, FCPS

Role: backup

Shahid Majid, FCPS

Role: primary

Mohammad Salih, FCPS

Role: backup

Other Identifiers

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06GS013MED

Identifier Type: -

Identifier Source: org_study_id