Safety Study of Regional Citrate Anticoagulation Using the multiFiltratePRO System in Adults Requiring Continuous Renal Replacement Therapy

What this Trial Is About

This research aims to assess the safety of regional citrate anticoagulation RCA delivered by the multiFiltratePRO system in adult patients who need continuous renal replacement therapy CRRT. The study focuses on patients with acute kidney injury AKI or end-stage kidney disease ESKD, conditions common in intensive care settings and often requiring CRRT due to complications like multiple organ failure. The study explores RCA as an alternative to traditional anticoagulation, aiming to reduce bleeding risks and improve circuit patency during CRRT. Participants will receive RCA through the multiFiltratePRO system, which includes the Ci-Ca module, trisodium citrate 4% Cifoban, calcium chloride dihydrate Calrecia, specialized dialysates, and disposable cassettes. This open-label, multicenter study involves delivering RCA continuously to critically ill adults requiring CRRT, with treatments managed according to institutional protocols and device specifications. During the study, participants will be monitored for symptoms and blood levels of ionized calcium, arterial pH, bicarbonate, serum sodium, hemoglobin changes, and calcium ratios for up to one month. Circuit life will also be observed, with each circuit lasting up to 72 hours before replacement. The study involves regular clinical assessments, laboratory tests, and safety monitoring to evaluate the anticoagulation methods effects and potential risks over the treatment period.

SAfety of Regional Citrate Anticoagulation (SARCA Study)