PEG3350 in ACLF With Hepatic Encephalopathy

• Status: Unknown status
• Trial end date: 2020-08-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Lactulose; Polyethylene glycol 3350

Criteria

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.