Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - a Randomized Clinical Trial in Acute Kidney Injury

Trial ID or NCT#

NCT05758077

Status

recruiting iconRECRUITING

Purpose

This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.

Official Title

A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Investigator(s)

Vikram Fielding-Singh
Clinical Assistant Professor, Anesthesiology, Perioperative and Pain Medicine Masters Student in Epidemiology and Clinical Research, admitted Autumn 2024
Glenn M. Chertow
Glenn M. Chertow
Nephrologist
Norman S. Coplon/Satellite Healthcare Professor of Medicine and Professor, by courtesy, of Epidemiology and Population Health and of Health Policy

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Contact

Mohamed Zidan, MD
844-427-8100