Polyethylene Glycol Versus Lactulose on Hepatic Encephalopathy in Patients With Cirrhosis;(PEGHE Trial)
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
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 excess ammonia in the brain, as the liver is unable to metabolize the
ammonia. The common gold standard treatment recommended for patients with Hepatic
Encephalopathy is Lactulose syrup. This is a non absorbable sugar, often combined with an
antibiotic called Rifaxamine to treat this condition.
Polyethylene glycol is in a class of medications called osmotic laxatives which works by
causing water to be retained with the stool. PEG and lactulose, when used together, result in
faster resolution of symptoms suggesting that PEG may be superior to standard lactulose
therapy in these patients.
Non-absorbable sugars like lactulose are associated with non-serious (mainly
gastrointestinal) adverse events like diarrhea and bloating Hence, due to the side effect
profile, newer drugs continue to be tested for treatment of Hepatic Encephalopathy.
The aim of this research project is to compare the effect of PEG versus lactulose for
treatment of HE in patients with liver cirrhosis. The investigators want to compare the
resolution of HE as the main outcome. In addition, they will compare length of stay,
non-serious (mainly gastrointestinal) adverse events, and 3 months outcome. The investigators
hypothesize that rapid purgation of the gut using PEG may resolve HE more effectively than
lactulose.