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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115697
Recruitment Status : Withdrawn (lack of funds)
First Posted : April 14, 2017
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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)


Condition or disease Intervention/treatment Phase
Refractory Hepatic Encephalopathy Drug: Lactulose Drug: Rifaximin Biological: Plasmapheresis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial
Actual Study Start Date : April 7, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lactulose with Rifaximin Drug: Lactulose
Lactulose 20 mL

Drug: Rifaximin
Rifaximin 550 BD

Experimental: 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)
Biological: Plasmapheresis
Plasmapheresis 8 hrly duration




Primary Outcome Measures :
  1. Resolution in Hepatic Encephalopathy by 2 grades in both groups [ Time Frame: Day 5 ]

Secondary Outcome Measures :
  1. Improvement in Hepatic Encephalopathy in both groups [ Time Frame: 2 years ]
  2. Number of days of mechanical ventilation in both groups [ Time Frame: 2 years ]
  3. Survival in both groups [ Time Frame: 28 days ]
  4. Proportion of patients with Systemic inflammatory response syndrome (SIRS) or sepsis as precipitants of Hepatic encephalopathy in both groups. [ Time Frame: 2 years ]
  5. Proportion of patients with failure of standard medical therapy in both groups. [ Time Frame: 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115697


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03115697    
Other Study ID Numbers: ILBS-HE-01
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Lactulose
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents