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

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Jul 18, 2024

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ClinConnect Summary

This clinical trial is investigating the effects of two different approaches to a treatment called plasma exchange in patients who have acute liver failure and swelling in the brain, known as cerebral edema. The study aims to find out whether using a high volume of plasma exchange is better than a standard volume in helping patients recover from brain swelling. Patients with acute liver failure, which means they have yellowing of the skin (jaundice) and mental confusion, may qualify for this study if they are between the ages of 18 and 70 and have specific conditions documented by medical tests.

Participants in the trial will be randomly assigned to one of two groups: one will receive high-volume plasma exchange, while the other will receive the standard treatment. The main goal is to see how quickly patients improve from their brain swelling, as well as to monitor any side effects from the treatment, such as difficulty breathing or allergic reactions. This trial is important because it may help doctors understand the best way to treat patients with severe liver issues, which can be life-threatening. If you or a loved one is interested in participating, please speak with your healthcare provider to see if you meet the eligibility criteria.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 1. Age \<18 or \> 70 years
• • 2. HCC
• • 3. Active untreated Sepsis/DIC
• • 4. Hemodynamic instability non-responsive to initial fluid resuscitation with norepinephrine \>0.1 ug/kg/min
• • 5. Post-resection and malignancy related liver failure
• • 6. Coma of non-hepatic origin
• • 7. Patients with uncontrolled infection
• • 8. Patients with pulmonary involvement with Pa02/Fio2 ratio below 200.
• • 9. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
• • 10. Extremely moribund patients with an expected life expectancy of less than 24 hours
• • 11. Pregnancy related liver failure
• • 12. 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)
• • 13. Refusal to participate in the study
• • 14. Drug-induced ALF