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ENROLLING BY INVITATION
NCT06987604
NA

Continuous Renal Replacement Therapy Intensity in Hyperammonemia

Sponsor: Hospital de Clinicas de Porto Alegre

View on ClinicalTrials.gov

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.

Official title: Continuous Renal Replacement Therapy Intensity in TreatIng Critical Ammonemia Levels

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2025-03-14

Completion Date

2029-05-14

Last Updated

2025-06-24

Healthy Volunteers

No

Interventions

DEVICE

High-dose continuous renal replacement therapy

Continuous renal replacement therapy administered at an effluent dose of 45-55 mL/kg/h using standard equipment and protocols for critically ill patients with ALF or ACLF and hyperammonemia.

DEVICE

Conventional-dose continuous renal replacement therapy

Continuous renal replacement therapy administered at an effluent dose of 25-35 mL/kg/h using standard equipment and protocols for critically ill patients with ALF or ACLF and hyperammonemia.

Locations (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil