Study Stopped
lack of funds
High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.
1 other identifier
interventional
N/A
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedStudy Start
First participant enrolled
April 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2019
CompletedNovember 4, 2019
November 1, 2019
1 year
April 12, 2017
November 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Resolution in Hepatic Encephalopathy by 2 grades in both groups
Day 5
Secondary Outcomes (5)
Improvement in Hepatic Encephalopathy in both groups
2 years
Number of days of mechanical ventilation in both groups
2 years
Survival in both groups
28 days
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
Study Arms (2)
Lactulose with Rifaximin
ACTIVE COMPARATORPlasmapheresis
EXPERIMENTALPlasmapheresis 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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2017
First Posted
April 14, 2017
Study Start
April 7, 2018
Primary Completion
April 15, 2019
Study Completion
April 15, 2019
Last Updated
November 4, 2019
Record last verified: 2019-11