Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

PEG3350 in ACLF With Hepatic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03987893
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Radha K Dhiman, Postgraduate Institute of Medical Education and Research

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Acute-On-Chronic Liver Failure Drug: PEG-3350 with Electolytes Drug: Lactulose Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open Label, randomized control trial
Masking: None (Open Label)
Masking Description: participant is randomised using a table of random numbers.
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy of Oral PEG3350 Plus Lactulose Versus Lactulose Alone in Patients of Acute on Chronic Liver Failure With Overt Hepatic Encephalopathy: A Single Blind Prospective Randomized Controlled Study
Actual Study Start Date : May 20, 2018
Estimated Primary Completion Date : May 25, 2020
Estimated Study Completion Date : August 20, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lactulose

Arm Intervention/treatment
Experimental: PEG+Lactulose
this arm will recieve PEG3350 in addition to standard of care
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
Other Name: Lactulose per orally

Active Comparator: Lactulose alone
this arm will recieve only standard of care for management of hepatic encephlaopathy with ACLF
Drug: Lactulose
Lactulose will be given orally (30ml QID) which shall be titrated to ensure 2-3 soft stools per day
Other Name: Lactulose per orally




Primary Outcome Measures :
  1. Improvement in survival. [ Time Frame: At day 28 and day 90. ]
    to look for any survival benefit in experimental arm at 28 days and 90 days

  2. Improvement of encephalopathy by one or more grades. [ Time Frame: 24 hours, 48 hours and 72 hours ]
    to look for the degree of improvement in grade of HE in both experimental arm and lactulose arm.


Secondary Outcome Measures :
  1. Reduction in ammonia levels during and at the end of 48 hours, 72 hours and lactulose administration [ Time Frame: 24 hours, 48 hours and 72 hours ]
    to extrapolate weather reduction of grade of HE correlates with reduction of ammonia levels

  2. Prolongation of time to death among non-survivors. [ Time Frame: 30 days ]
    to analyse the difference in time to event(death) among non survivors in experimental arm

  3. Prevention / reduction of cerebral edema [ Time Frame: 72 hours ]
    to look for any evidence of cerebral edema reduction by means of optic nerve sheath diameter

  4. Reduction of seizures frequency [ Time Frame: 30 days ]
    to analyse if reduction of HEresults in reduction or prevention of seizure episodes in both arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987893


Contacts
Layout table for location contacts
Contact: Syed Ahmed, MD 9035821510 syedusman92@gmail.com

Locations
Layout table for location information
India
Postgraduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Radha K Dhiman, DM    7087009337    rkpsdhiman@hotmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Layout table for investigator information
Study Chair: Madhumita Premkumar, DM Postgraduate Institute of Medical Education and Research

Layout table for additonal information
Responsible Party: Radha K Dhiman, Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03987893     History of Changes
Other Study ID Numbers: INT/IEC/2018-000485
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Radha K Dhiman, Postgraduate Institute of Medical Education and Research:
PEG3350
hepatic encephalopathy
acute on chronic liver failure
lactulose
rifaximin
HESA

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Failure
Hepatic Insufficiency
Hepatic Encephalopathy
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Liver Failure, Acute
Lactulose
Polyethylene glycol 3350
Gastrointestinal Agents
Laxatives