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

Institute of Liver and Biliary Sciences, India

Status: Withdrawn

Conditions: Refractory Hepatic Encephalopathy

Treatments: Drug: Lactulose; Drug: Rifaximin; Biological: Plasmapheresis

Study type: Interventional

Funder types: Other

Identifiers

NCT03115697

ILBS-HE-01

Details and patient eligibility

About

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)

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Lactulose with Rifaximin

Active Comparator group

Treatment:

Drug: Lactulose

Drug: Rifaximin

Plasmapheresis

Experimental group

Description:

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)

Treatment:

Biological: Plasmapheresis