Back to resultsHigh Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.
Primary Purpose
Refractory Hepatic Encephalopathy
Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Lactulose
Rifaximin
Plasmapheresis
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Hepatic Encephalopathy
Eligibility 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.
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lactulose with Rifaximin
Plasmapheresis
Arm Description
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)
Outcomes
Primary Outcome Measures
Resolution in Hepatic Encephalopathy by 2 grades in both groups
Secondary Outcome Measures
Improvement in Hepatic Encephalopathy in both groups
Number of days of mechanical ventilation in both groups
Survival in both groups
Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups.
Proportion of patients with failure of standard medical therapy in both groups.
Full Information
NCT ID
NCT03115697
First Posted
April 12, 2017
Last Updated
November 1, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03115697
Brief Title
High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.
Official Title
High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funds
Study Start Date
April 7, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Anticipated)
Study Completion Date
April 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Hepatic Encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactulose with Rifaximin
Arm Type
Active Comparator
Arm Title
Plasmapheresis
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
Lactulose 20 mL
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
Rifaximin 550 BD
Intervention Type
Biological
Intervention Name(s)
Plasmapheresis
Intervention Description
Plasmapheresis 8 hrly duration
Primary Outcome Measure Information:
Title
Resolution in Hepatic Encephalopathy by 2 grades in both groups
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Improvement in Hepatic Encephalopathy in both groups
Time Frame
2 years
Title
Number of days of mechanical ventilation in both groups
Time Frame
2 years
Title
Survival in both groups
Time Frame
28 days
Title
Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups.
Time Frame
2 years
Title
Proportion of patients with failure of standard medical therapy in both groups.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.
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