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

Aga Khan University

Status and phase: Unknown; Phase 3

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

Treatments: Drug: Placebo; Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT00553423

06GS013MED

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Lactulose 30 ml q6h for 48 hrs

Treatment:

Drug: Lactulose

2

Placebo Comparator group

Description:

Placebo 30 ml q6 hrly for 48hrs

Treatment:

Drug: Placebo