High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.

Study Overview
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Brief Summary
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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)

Official Title
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High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial

Conditions
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Refractory Hepatic Encephalopathy

Intervention / Treatment
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* Drug: Lactulose
* Drug: Rifaximin
* Biological: Plasmapheresis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactulose with Rifaximin<br> | Drug: Lactulose<br>* Lactulose 20 mL<br>Drug: Rifaximin<br>* Rifaximin 550 BD<br>|
| Experimental: Plasmapheresis<br>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) | Biological: Plasmapheresis<br>* Plasmapheresis 8 hrly duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution in Hepatic Encephalopathy by 2 grades in both groups |  | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |