Polyethylene Glycol Versus Lactulose on Hepatic Encephalopathy in Patients With Cirrhosis;(PEGHE Trial)
Launched by AGA KHAN UNIVERSITY · Jun 17, 2020
Trial Information
Current as of July 21, 2025
Unknown status
Keywords
ClinConnect Summary
The PEGHE Trial is a research study aimed at comparing two treatments for a condition called hepatic encephalopathy, which can occur in patients with liver cirrhosis. Hepatic encephalopathy can cause symptoms like confusion and sleep disturbances due to a buildup of ammonia in the brain. Traditionally, patients are treated with a syrup called lactulose, but this study is exploring whether another option called polyethylene glycol (PEG) might work better. PEG is a type of laxative that helps clear the gut more quickly, and researchers want to see if it can help resolve the symptoms of hepatic encephalopathy faster than lactulose alone.
To participate in this trial, individuals must be between 18 and 80 years old and have chronic liver disease and symptoms of hepatic encephalopathy. They need to be admitted to Aga Khan University Hospital and have a family member available to give consent. Participants can expect to receive either PEG or lactulose and will be monitored for how well their symptoms improve, along with any side effects they might experience. This study is important because it could lead to better treatment options for patients suffering from this challenging condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. All patients of 18-80 years admitted to Aga Khan University Hospital
- • 2. With Chronic liver disease: Chronic liver disease will be defined based on ultra-sonographic evidence of chronic liver disease including shrunken liver, dilated portal vein, splenomegaly.
- • 3. With Hepatic encephalopathy; Hepatic encephalopathy will be defined as the onset of disorientation or asterixis according to The International Society for Hepatic Encephalopathy and Nitrogen Metabolism consensus and will be assessed using HESA score
- • 4. Presence of first degree relative for consent (Next of kin)
- Exclusion Criteria:
- • 1. Allergy to PEG
- • 2. Bowel obstruction or perforation diagnosed clinically or on Xray
- • 3. Major psychiatric illness; on benzodiazepines
- • 4. Treated with locally acting antibiotics (rifaximin) in the previous 7 days;
- • 5. Active gastrointestinal tract bleeding
- • 6. Acute Liver failure:defined as coagulopathy (international normalized ratio \>1.5) with any degree of AMS in the absence of underlying chronic liver disease (CLD)
- • 7. Female patients if pregnant or lactating
About Aga Khan University
Aga Khan University (AKU) is a distinguished institution dedicated to improving health and education across developing regions. Established in 1983, AKU is recognized for its commitment to research excellence, particularly in clinical trials that address pressing health issues in diverse populations. With a focus on advancing medical knowledge and practice, AKU's clinical trial initiatives are designed to foster innovative solutions and enhance patient care. The university collaborates with various local and international partners, leveraging its multidisciplinary expertise to conduct rigorous research that informs public health policy and improves health outcomes in communities served by its facilities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Karachi, Sindh, Pakistan
Patients applied
Trial Officials
Om Parkash
Principal Investigator
Aga Khan University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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