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

Not Applicable

Withdrawn

• Conditions: Refractory Hepatic Encephalopathy
• Interventions: Drug: Lactulose; Biological: Plasmapheresis; Drug: Rifaximin

• Registration Number: NCT03115697
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-14
• Study Start: 2018-04-07
• Primary Completion: 2019-04-15
• Study Completion: 2019-04-15
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose with Rifaximin	Rifaximin	-
Lactulose with Rifaximin	Lactulose	-
Plasmapheresis	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)

Primary Outcome Measures

Name	Time	Method
Resolution in Hepatic Encephalopathy by 2 grades in both groups	Day 5

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India