Status:
UNKNOWN
Polyethylene Glycol Versus Lactulose on Hepatic Encephalopathy in Patients With Cirrhosis;(PEGHE Trial)
Lead Sponsor:
Aga Khan University
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Hepatic Encephaopathy is a common complication occurring in patients with Liver cirrhosis. Patients usually develop mild confusion, sleep disturbance or obtundation. It occurs due to accumulation of e...
Detailed Description
Hepatic encephalopathy (HE) is a common neuropsychiatric complication of liver cirrhosis manifested by mild confusion, sleep disturbance or obtundation. Lactulose treatment has long been the standard ...
Eligibility Criteria
Inclusion
- All patients of 18-80 years admitted to Aga Khan University Hospital
- 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.
- 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
- Presence of first degree relative for consent (Next of kin)
Exclusion
- Allergy to PEG
- Bowel obstruction or perforation diagnosed clinically or on Xray
- Major psychiatric illness; on benzodiazepines
- Treated with locally acting antibiotics (rifaximin) in the previous 7 days;
- Active gastrointestinal tract bleeding
- 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)
- Female patients if pregnant or lactating
Key Trial Info
Start Date :
March 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04436601
Start Date
March 9 2020
End Date
December 30 2023
Last Update
April 19 2023
Active Locations (1)
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1
Aga Khan University
Karachi, Sindh, Pakistan, 75290