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PEG3350 in ACLF With Hepatic Encephalopathy

NCT03987893 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-06-17

No results posted yet for this study

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.

Conditions

  • Hepatic Encephalopathy
  • Acute-On-Chronic Liver Failure

Interventions

DRUG

PEG-3350 with Electolytes

experimental arm will receive 2 doses of PEG3350 spaced over 12 hours after randomization to arm1. PEG as dose of 2litres (1 sachet dissolved in 2L of water) will be administered via a nasogastric tube.

DRUG

Lactulose

Lactulose will be given orally (30ml QID) which shall be titrated to ensure 2-3 soft stools per day

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Madhumita Premkumar, DM · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-20
Primary Completion
2020-05-25
Completion
2020-08-20

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03987893 on ClinicalTrials.gov