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ACTIVE NOT RECRUITING
NCT06811805
NA

Post-Marketing Study to Assess the Safety & Efficacy of RenalGuard® Therapy for Prevention CSA-AKI

Sponsor: CardioRenal Systems, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated AKI (CSA-AKI) compared to standard-of-care (SoC). Participants will be randomized (1:1) to one of the two study groups. The Treatment study group will be managed with the RenalGuard System. The RenalGuard treatment will start after induction of anesthesiology and will run during surgery and for 6-7 hours in the Intensive Care Unit (ICU). The treatment will aim to achieve a urine rate above a predefined urine rate threshold. Patients in the control group will be managed based on the usual clinical practice in cardiac surgery centres as detailed in the recommendations for CSA-AKI prevention by accepted clinical guidelines. For both study groups general anaesthesia, cardiopulmonary bypass (CPB) run and overall patient care will be based on SoC for cardiac surgery. Patients will be followed up for up to 7 days post surgery or until discharge, which ever comes first. Long-term follow up will be performed at 90 days post surgery.

Official title: Post-Marketing Clinical Follow Up Study to Further Assess the Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-02-23

Completion Date

2028-04-30

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DEVICE

RenalGuard Therapy

RenalGuard Therapy

OTHER

Standard of Care (SOC)

Standard of care

Locations (8)

Jessa Medica Center

Hasselt, Belgium

TUM Klinikum Deutsches Herzzentrum

Munich, Germany

Uniklinikum Munster

Münster, Germany

Rambam Medical Center

Haifa, Israel

Rabin Medical Center - Belinson Campus

Petah Tikva, Israel

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Sahlgrenska University Hospital

Gothenburg, Sweden