Clinical Trial

Continuous Renal Replacement Therapy Intensity in Hyperammonemia

Study acronym: CRITICAL
Enrolling by Invitation
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Summary
Acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) are life-threatening conditions often associated with hyperammonemia, hepatic encephalopathy, and multi-organ dysfunction. Ammonia plays a central role in the pathogenesis of cerebral edema and neurotoxicity. Continuous renal replacement therapy (CRRT) has been shown to effectively reduce serum ammonia levels and may improve transplant-free survival in ALF. However, the optimal dialysis dose for ammonia clearance and neurological recovery remains uncertain. This randomized, multicenter clinical trial aims to compare conventional-dose (25-35 mL/kg/h) versus high-dose (45-55 mL/kg/h) CRRT in patients with ALF or ACLF and arterial ammonia \>72 μmol/L. The primary outcome is the number of coma- and delirium-free days. Secondary outcomes include ammonia clearance and additional parameters of cerebral function monitoring.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-16.
Trial Details
NCT Number NCT06987604
Lead Sponsor Hospital de Clinicas de Porto Alegre
Collaborators: FIPE - Fundo de Incentivo a Pesquisa do Hospital de Clínicas de Porto Alegre
Conditions Acute Liver Failure, Acute on Chronic Liver Failure (ACLF), Acute Kidney Injury, Ammonia Metabolism
Enrollment 152 participants
Start Date 2025-03-14
Primary Completion 2029-05-14 (estimated)
Study Completion 2029-05-14 (estimated)
Updated on ClinicalTrials.gov 2025-06-24