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

Last updated: November 2, 2007
Sponsor: Aga Khan University
Overall Status: Trial Status Unknown

Phase

3

Condition

Hepatic Encephalopathy

Gastric Ulcers

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT00553423
06GS013MED
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years

  • All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy atthe time of admission in ER

Exclusion

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, orrespiratory 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 Design

Total Participants: 128
Study Start date:
November 01, 2007
Estimated Completion Date:
November 30, 2008

Study 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.

Connect with a study center

  • Aga Khan University

    Karachi, Sind 74800
    Pakistan

    Active - Recruiting

  • Aga Khan university

    Karachi, Sind 74800
    Pakistan

    Site Not Available

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