drugset / Trial / NCT03115697
High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.
RandomizedParallel-groupOpen-labelTreatment
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)
Timeline
- Start
- 2018-04-07
- Primary completion
- 2019-04-15
- Completion
- 2019-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lactulose | Other / unclassified | 20 ml | — |
| Comparator | Rifaximin | Other / unclassified | — | — |