High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.
NCT ID: NCT03115697
Last Updated: 2019-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-04-07
2019-04-15
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lactulose with Rifaximin
Lactulose
Lactulose 20 mL
Rifaximin
Rifaximin 550 BD
Plasmapheresis
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)
Plasmapheresis
Plasmapheresis 8 hrly duration
Interventions
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Lactulose
Lactulose 20 mL
Rifaximin
Rifaximin 550 BD
Plasmapheresis
Plasmapheresis 8 hrly duration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Other Identifiers
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ILBS-HE-01
Identifier Type: -
Identifier Source: org_study_id
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