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

NCT03115697 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-11-04

No results posted yet for this study

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)

Conditions

  • Refractory Hepatic Encephalopathy

Interventions

DRUG

Lactulose

Lactulose 20 mL

DRUG

Rifaximin

Rifaximin 550 BD

BIOLOGICAL

Plasmapheresis

Plasmapheresis 8 hrly duration

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-07
Primary Completion
2019-04-15
Completion
2019-04-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03115697 on ClinicalTrials.gov