Status:
NOT_YET_RECRUITING
High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Acute Liver Failure
Cerebral Edema
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
In this prospective randomized controlled trial Investigator aim to evaluate the impact of high versus standard volume plasma-exchange in patients with acute liver failure with cerebral edema and clin...
Detailed Description
All patients will undergo plain CT-scan of the brain to screen for the presence and severity of cerebral edema in the emergency before being shifted to the L-ICU. In the L- ICU, patients will be manag...
Eligibility Criteria
Inclusion
- Patients with acute liver failure defined as patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease.
- Cerebral edema documented on CT-scan and arterial ammonia \>150 ug/dL
Exclusion
- Age \<18 or \> 70 years
- HCC
- Active untreated Sepsis/DIC
- Hemodynamic instability non-responsive to initial fluid resuscitation with norepinephrine \>0.1 ug/kg/min
- Post-resection and malignancy related liver failure
- Coma of non-hepatic origin
- Patients with uncontrolled infection
- Patients with pulmonary involvement with Pa02/Fio2 ratio below 200.
- Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
- Extremely moribund patients with an expected life expectancy of less than 24 hours
- Pregnancy related liver failure
- Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease)
- Refusal to participate in the study
- Drug-induced ALF
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06515145
Start Date
December 1 2025
End Date
March 1 2026
Last Update
September 19 2025
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070