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

• Status: Withdrawn
• Trial end date: 2019-04-15
• Target enrollment: 0
• Participant gender: All

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)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Lactulose; Rifaximin

Criteria

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.