High-volume Versus Standard Volume Plasma Exchange in Patients With Acute Liver Failure With Cerebral Edema

Not Applicable

Not yet recruiting

• Conditions: Acute Liver Failure; Cerebral Edema

• Registration Number: NCT06515145
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-6-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br>Patients with acute liver failure defined as patients with jaundice which is complicated<br>by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without<br>underlying chronic liver disease.<br><br>Cerebral edema documented on CT-scan and arterial ammonia >150 ug/dL<br><br>Exclusion Criteria:<br><br> 1. Age <18 or > 70 years<br><br> 2. HCC<br><br> 3. Active untreated Sepsis/DIC<br><br> 4. Hemodynamic instability non-responsive to initial fluid resuscitation with<br> norepinephrine >0.1 ug/kg/min<br><br> 5. Post-resection and malignancy related liver failure<br><br> 6. Coma of non-hepatic origin<br><br> 7. Patients with uncontrolled infection<br><br> 8. Patients with pulmonary involvement with Pa02/Fio2 ratio below 200.<br><br> 9. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis,<br> interstitial nephritis or vasculitis based on clinical history and urine analysis<br><br> 10. Extremely moribund patients with an expected life expectancy of less than 24 hours<br><br> 11. Pregnancy related liver failure<br><br> 12. Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe<br> cardiopulmonary disease defined by a New York Heart Association score >3, or<br> oxygen/steroid-dependent chronic obstructive pulmonary disease)<br><br> 13. Refusal to participate in the study<br><br> 14. Drug-induced ALF

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to improvement in cerebral edema

Secondary Outcome Measures

Name	Time	Method
To study the adverse events of therapy;Transplant-free survival at day 21