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

NCT00553423 | Unknown Phase 3 DMC

• 1 other identifier: 06GS013MED
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Development of Clinically Overt Hepatic Encephalopathy

  48hours

Secondary Outcomes (1)

• Death, hospital stay

  48hrs

Study Arms (2)

1

EXPERIMENTAL

Lactulose 30 ml q6h for 48 hrs

Drug: Lactulose

2

PLACEBO COMPARATOR

Placebo 30 ml q6 hrly for 48hrs

Drug: Placebo

Interventions

Lactulose DRUG

Lactulose 30 ml q6h for 48 hrs

1

Placebo DRUG

Placebo 30 ml q6hrly for 48 hrs

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in ER

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (2)

Aga Khan university

Karachi, Sindh, 74800, Pakistan

NOT YET RECRUITING

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Shahid Majid, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Mohammad Salih, FCPS

  Aga Khan University

  STUDY DIRECTOR

• Shahid Ahmed, FCPS

  Aga Khan University

  STUDY DIRECTOR

• Wasim Jafri, FCPS

  Aga Khan University

  STUDY CHAIR

Central Study Contacts

Shahid Majid, FCPS

CONTACT

9221-4930051; shahid.majid@aku.edu

Mohammad Salih, FCPS

CONTACT

9221-4930051; mohammad.salih@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: November 1, 2007
• Study Completion: November 1, 2008
• Last Updated: November 5, 2007

Record last verified: 2007-10

Locations

PA (2)