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

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

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)

Study Overview

• Status: Withdrawn
• Conditions: Refractory Hepatic Encephalopathy
• Intervention / Treatment: Drug: Lactulose; Drug: Rifaximin; Biological: Plasmapheresis

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Resolution in Hepatic Encephalopathy by 2 grades in both groups	Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival in both groups	28 days
Improvement in Hepatic Encephalopathy in both groups	2 years
Number of days of mechanical ventilation in both groups	2 years
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2018
• Primary Completion (Anticipated): April 15, 2019
• Study Completion (Anticipated): April 15, 2019

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin; Lactulose
• Other Study ID Numbers: ILBS-HE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No