RecruitingPhase 3NCT05339139

SAfety of Regional Citrate Anticoagulation (SARCA Study)

An Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO System in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study)

Sponsor

Fresenius Medical Care North America

Enrollment

50 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Kidney Injury ESRD

Summary

This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a type of kidney dialysis anticoagulation called regional citrate anticoagulation (RCA) — which uses citrate instead of heparin to prevent blood clotting in dialysis machines — is safe for critically ill patients who need continuous kidney support therapy (CRRT). **You may be eligible if...** - You are 18 years or older - You have acute kidney injury (AKI) or end-stage kidney disease (ESKD) requiring continuous kidney replacement therapy (dialysis) - You have appropriate dialysis catheter access in place **You may NOT be eligible if...** - You have metabolic alkalosis (high blood pH/bicarbonate levels) - You are pregnant or breastfeeding - You have severe liver disease - You have certain metabolic or electrolyte conditions that make citrate unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTDialysis

In this study critically ill adult patients requiring Continuous Renal Replacement Therapy (CRRT) will receive Regional Citrate Anticoagulation (CRA) which will be delivered by multiFiltratePRO system.