UnknownPhase 4

PEG3350 in ACLF With Hepatic Encephalopathy

India60 participantsStarted 2018-05-20

Plain-language summary

it is a single blind randomised control study which aims to study the effect of PEG3350 in resolution of overt hepatic encephalopathy in patients of acute on chronic liver failure. this will be compared with the standard of care in the management of hepatic encephalopathy.

Who can participate

Age range18 Years – 75 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: * Age 18-75 years. * Patients with ACLF with presence of hepatic encephalopathy \> grade 2 as per WHC Exclusion Criteria: * Pregnant women or those who are suspected to be having acute fatty liver of pregnancy * Malarial hepatopathy, enteric hepatitis, or ischemic hepatitis. * Serum Na \<125 mEq/litre * Gastrointestinal (GI) obstruction, ileus, or gastric retention * Bowel perforation * Toxic colitis or toxic megacolon * Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam) * Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy * Uncontrolled infection with hemodynamic instability requiring vasopressors.

What they're measuring

Improvement in survival.

Timeframe: At day 28 and day 90.

Improvement of encephalopathy by one or more grades.

Timeframe: 24 hours, 48 hours and 72 hours

Trial details

NCT IDNCT03987893

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-25

Contact for this trial

Syed Ahmed, MD

9035821510 syedusman92@gmail.com

View on ClinicalTrials.gov More Hepatic Encephalopathy trials