High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03115697

Collaborator

(none)

Enrollment

Location

Arms

12.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study Design- Randomized Controlled trial Duration of enrolment-Feb-2016 to December 2017 Sample size-120 patients Methodology We will include consecutive with advanced hepatic encephalopathy not responding to treatment of precipitants and on treatment with Lactulose and Rifaximin for 48 hours .

Two groups will be divided. One arm -Lactulose and Rifaximin will be continued Second Arm - Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)

Condition or Disease	Intervention/Treatment	Phase
Refractory Hepatic Encephalopathy	Drug: Lactulose Drug: Rifaximin Biological: Plasmapheresis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial

Actual Study Start Date :

Apr 7, 2018

Anticipated Primary Completion Date :

Apr 15, 2019

Anticipated Study Completion Date :

Apr 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lactulose with Rifaximin	Drug: Lactulose Lactulose 20 mL Drug: Rifaximin Rifaximin 550 BD
Experimental: Plasmapheresis Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)	Biological: Plasmapheresis Plasmapheresis 8 hrly duration

Arm

Intervention/Treatment

Active Comparator: Lactulose with Rifaximin

Drug: Lactulose

Lactulose 20 mL

Drug: Rifaximin

Rifaximin 550 BD

Experimental: Plasmapheresis

Plasmapheresis will be added to the standard medical care therapy.(Maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)

Biological: Plasmapheresis

Plasmapheresis 8 hrly duration

Outcome Measures

Primary Outcome Measures

Resolution in Hepatic Encephalopathy by 2 grades in both groups [Day 5]

Secondary Outcome Measures

Improvement in Hepatic Encephalopathy in both groups [2 years]
Number of days of mechanical ventilation in both groups [2 years]
Survival in both groups [28 days]
Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups. [2 years]
Proportion of patients with failure of standard medical therapy in both groups. [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cirrhotics
Age between 18-70 years
Hepatic encephalopathy -Grade 3-4
Patients receiving Lactulose/Rifaximin for 48 hours and not showing improvement in Hepatic encephalopathy(Persistent Grade 3/4)

Exclusion Criteria:

Concomitant participation in an other clinical trial
Patient receiving sedatives(propofol,etc) 24 hours prior.
Patients with severe cardiopulmonary disease
Pregnancy
Human Immunodeficiency Virus
Hepatocellular Carcinoma or extrahepatic malignancy
Active uncontrolled sepsis with hemodynamic instability
Chronic renal insufficiency on treatment with haemodialysis
Uncontrolled bleed or patients in DIC
Extremely moribund patients with expected survival of less than 48 hours on high vasopressor support
Patients with moderate-severe Acute Respiratory Distress Syndrome (ARDS).
Patients with Non Hepatic Coma.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT03115697

Other Study ID Numbers:

ILBS-HE-01

First Posted:

Apr 14, 2017

Last Update Posted:

Nov 4, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatic Encephalopathy

Brain Diseases

Rifaximin

Lactulose

Study Results

No Results Posted as of Nov 4, 2019