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

NCT03115697 — Not applicable, Withdrawn, Institute of Liver and Biliary Sciences, India
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High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit-A Randomized Controlled Trial

RegistryNCT03115697
StatusWithdrawn - lack of funds
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
SponsorInstitute of Liver and Biliary Sciences, India (Other)
ConditionsRefractory Hepatic Encephalopathy
InterventionsLactulose, Rifaximin, Plasmapheresis (Drug, biological)
Datesstart 2018-04-07, primary completion 2019-04-15 (estimated), completion 2019-04-15 (estimated), first posted 2017-04-14, last updated 2019-11-04
Locations1 site in India

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-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)

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+Arms and interventions

ArmTypeInterventionsDescription
Lactulose with RifaximinActive comparatorDrug: Lactulose; Drug: Rifaximin
PlasmapheresisExperimentalBiological: PlasmapheresisPlasmapheresis 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)
  • Lactulose (Drug): Lactulose 20 mL
  • Rifaximin (Drug): Rifaximin 550 BD
  • Plasmapheresis (Biological): Plasmapheresis 8 hrly duration

+Outcome measures

Primary outcomes

  • Resolution in Hepatic Encephalopathy by 2 grades in both groups [Day 5]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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.

+Locations (1)

FacilityCityCountryStatus
Institute of Liver and Biliary SciencesNew Delhi, National Capital Territory of DelhiIndia

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