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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00553423

Enrollment

128

Registered

2007-11-05

Start date

2007-11-30

Completion date

2008-11-30

Last updated

2007-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

DRUGLactulose

Lactulose 30 ml q6h for 48 hrs

DRUGPlacebo

Placebo 30 ml q6hrly for 48 hrs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Development of Clinically Overt Hepatic Encephalopathy	48hours

Secondary

Measure	Time frame
Death, hospital stay	48hrs

Countries

Pakistan

Contacts

Primary ContactShahid Majid, FCPS

shahid.majid@aku.edu9221-4930051

Backup ContactMohammad Salih, FCPS

mohammad.salih@aku.edu9221-4930051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026