NCT03115697

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Refractory Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Lactulose	Lactulose 20 mL
DRUG	Rifaximin	Rifaximin 550 BD
BIOLOGICAL	Plasmapheresis	Plasmapheresis 8 hrly duration

Timeline

• Start date: 2018-04-07
• Primary completion: 2019-04-15
• Completion: 2019-04-15
• First posted: 2017-04-14
• Last updated: 2019-11-04

Locations

1 site across 1 country: India