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

NCT06811805 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • AKI - Acute Kidney Injury
  • Cardiac Surgery Associated - Acute Kidney Injury

Interventions

DEVICE

RenalGuard Therapy

RenalGuard Therapy

OTHER

Standard of Care (SOC)

Standard of care

Sponsors & Collaborators

  • CardioRenal Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Jacob Raphael, MD · Thomas Jefferson University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-23
Primary Completion
2027-12-31
Completion
2028-04-30

Countries

  • Belgium
  • Germany
  • Israel
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06811805 on ClinicalTrials.gov