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Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03115697

Enrollment

Registered

2017-04-14

Start date

2018-04-07

Completion date

2019-04-15

Last updated

2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Hepatic Encephalopathy

Brief 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)

Interventions

DRUGLactulose

Lactulose 20 mL

DRUGRifaximin

Rifaximin 550 BD

BIOLOGICALPlasmapheresis

Plasmapheresis 8 hrly duration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
Resolution in Hepatic Encephalopathy by 2 grades in both groups	Day 5

Secondary

Measure	Time frame
Number of days of mechanical ventilation in both groups	2 years
Survival in both groups	28 days
Improvement in Hepatic Encephalopathy in both groups	2 years
Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups.	2 years
Proportion of patients with failure of standard medical therapy in both groups.	48 hours

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026