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

Institute of Liver and Biliary Sciences, India

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Refractory Hepatic Encephalopathy

Interventions

LactuloseDRUG

Lactulose 20 mL

RifaximinDRUG

Rifaximin 550 BD

PlasmapheresisBIOLOGICAL

Plasmapheresis 8 hrly duration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Resolution in Hepatic Encephalopathy by 2 grades in both groups

Time frame: Day 5

Secondary Outcomes

Improvement in Hepatic Encephalopathy in both groups

Time frame: 2 years

Number of days of mechanical ventilation in both groups

Time frame: 2 years

Survival in both groups

Time frame: 28 days

Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups.

Time frame: 2 years

Proportion of patients with failure of standard medical therapy in both groups.

Time frame: 48 hours

Data from ClinicalTrials.gov

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