To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hep… (NCT03448770) | Clinical Trial Compass
UnknownNot Applicable
To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.
India110 participantsStarted 2017-08-01
Plain-language summary
All patients presenting to the emergency department of Institute of Liver and Biliary Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in the study. The patient will be randomized into one of the two arms of lactulose or polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in 24 hours to ensure 3-4 loose stools per day.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Documented cirrhosis with any underlying etiology
✓. Hepatic encephalopathy of grade II and above
✓. 18 to 65 years of age
Exclusion criteria
✕. Acute change in mental status due to a diagnosis other than hepatic encephalopathy
✕. Patients who have received lactulose as an anticoma measure before enrollment
✕. Patient who have developed encephalopathy post bleed
✕. Patients with gut paralysis
✕. Patients with tense ascites
✕. Patients with altered sensorium due to organic brain disease.
✕. Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy
✕
What they're measuring
1
Complete reversal of hepatic encephalopathy in both groups.
Timeframe: 3 days
Trial details
NCT IDNCT03448770
SponsorInstitute of Liver and Biliary Sciences, India