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

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ClinicalTrials.gov Identifier: NCT00553423
Recruitment Status : Unknown
Verified October 2007 by Aga Khan University.
Recruitment status was:  Recruiting
First Posted : November 5, 2007
Last Update Posted : November 5, 2007
Information provided by:
Aga Khan University

November 2, 2007
November 5, 2007
November 5, 2007
November 2007
Not Provided
Development of Clinically Overt Hepatic Encephalopathy [ Time Frame: 48hours ]
Same as current
No Changes Posted
Death, hospital stay [ Time Frame: 48hrs ]
Same as current
Not Provided
Not Provided
Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
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

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hepatocerebral Encephalopathy
  • Portal-Systemic Encephalopathy
  • Encephalopathy, Hepatic
  • Encephalopathy, Hepatocerebral
  • Drug: Lactulose
    Lactulose 30 ml q6h for 48 hrs
  • Drug: Placebo
    Placebo 30 ml q6hrly for 48 hrs
  • Experimental: 1
    Lactulose 30 ml q6h for 48 hrs
    Intervention: Drug: Lactulose
  • Placebo Comparator: 2
    Placebo 30 ml q6 hrly for 48hrs
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
November 2008
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Aga Khan University
Not Provided
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
Aga Khan University
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP