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

This study is currently recruiting participants.
Verified by Aga Khan University, October 2007

Sponsored by: Aga Khan University
Information provided by: Aga Khan University
ClinicalTrials.gov Identifier: NCT00553423
  Purpose

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


Condition Intervention Phase
Hepatocerebral Encephalopathy
Portal-Systemic Encephalopathy
Encephalopathy, Hepatic
Encephalopathy, Hepatocerebral
Drug: Lactulose
Drug: Placebo
Phase III

MedlinePlus related topics:   Gastrointestinal Bleeding   

ChemIDplus related topics:   Lactulose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Development of Clinically Overt Hepatic Encephalopathy [ Time Frame: 48hours ]

Secondary Outcome Measures:
  • Death, hospital stay [ Time Frame: 48hrs ]

Estimated Enrollment:   128
Study Start Date:   November 2007
Estimated Study Completion Date:   November 2008

Arms Assigned Interventions
1: Experimental
Lactulose 30 ml q6h for 48 hrs
Drug: Lactulose
Lactulose 30 ml q6h for 48 hrs
2: Placebo Comparator
Placebo 30 ml q6 hrly for 48hrs
Drug: Placebo
Placebo 30 ml q6hrly for 48 hrs

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553423

Contacts
Contact: Shahid Majid, FCPS     9221-4930051 ext 4447     shahid.majid@aku.edu    
Contact: Mohammad Salih, FCPS     9221-4930051 ext 4528     mohammad.salih@aku.edu    

Locations
Pakistan, Sind
Aga Khan university     Not yet recruiting
      Karachi, Sind, Pakistan, 74800
      Contact: Shahid Majid, FCPS     9221-4930051 ext 4447     shahid.majid@aku.edu    
      Contact: Mohammad Salih, FCPS     9221-4930051 ext 4528     mohammad.salih@aku.edu    
      Principal Investigator: Shahid Majid, FCPS            
      Sub-Investigator: Mohammad Salih, FCPS            
      Sub-Investigator: Shahid Ahmed, FCPS            
      Sub-Investigator: Wasim Jafri, FRCP, FACG            
Aga Khan University     Recruiting
      Karachi, Sind, Pakistan, 74800
      Contact: Shahid Majid, FCPS     9221-4930051 ext 4447     shahid.majid@aku.edu    
      Contact: Mohammad Salih, FCPS     9221-4930051 ext 4528     mohammad.salih@aku.edu    

Sponsors and Collaborators
Aga Khan University

Investigators
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    
  More Information


Study ID Numbers:   06GS013MED
First Received:   November 2, 2007
Last Updated:   November 2, 2007
ClinicalTrials.gov Identifier:   NCT00553423
Health Authority:   Pakistan: Research Ethics Committee

Study placed in the following topic categories:
Liver Failure
Liver Diseases
Metabolic Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Central Nervous System Diseases
Hemorrhage
Brain Diseases
Hepatic Encephalopathy
Digestive System Diseases
Metabolic disorder
Lactulose
Hepatic Insufficiency
Brain Diseases, Metabolic

Additional relevant MeSH terms:
Pathologic Processes
Therapeutic Uses
Nervous System Diseases
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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