Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury

Last updated: January 13, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Completed

Phase

2

Condition

Kidney Disease

Kidney Failure

Renal Failure

Treatment

Normal saline

Deferoxamine

Clinical Study ID

NCT04633889
2020P003605
R01DK125786
  • Ages > 18
  • All Genders

Study Summary

Multiple lines of evidence support a central role of iron in causing acute kidney injury (AKI), including the finding that prophylactic administration of iron chelators attenuates AKI in animal models. Patients undergoing cardiac surgery may be particularly susceptible to iron-mediated kidney injury due to the profound hemolysis that often occurs from cardiopulmonary bypass. The investigators will test in a phase 2, randomized, double-blind, placebo-controlled trial whether prophylactic administration of deferoxamine decreases the incidence of AKI following cardiac surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years

  2. Undergoing coronary artery bypass graft and/or valve surgery with cardiopulmonarybypass

  3. AKI risk score ≥6 at the time of screening

  4. Written informed consent from the patient or surrogate

Exclusion

Exclusion Criteria:

  1. AKI, defined as any of the following:
  • Increase in serum creatinine ≥0.3 mg/dl in 48h

  • Increase in serum creatinine ≥50% in 7d (if no value available in last 7d, usemost recent value in last 3 months)

  • Urine output ≤0.5 ml/kg/h x 6 consecutive hours (only assessed in patients withhourly monitoring via Foley catheter)

  • Receipt of renal replacement therapy (RRT) within 7d

  1. Advanced chronic kidney disease (eGFR <15 ml/min/1.73m2 or end-stage kidney diseasereceiving RRT)

  2. Hemoglobin <8 g/dL (closest value in the prior 3 months)

  3. Fever (temperature ≥38⁰C) in the last 48h

  4. Suspected or confirmed bacteremia, endocarditis, or pyelonephritis

  5. Pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectiousetiology reported on chest x-ray or CT scan in the last 7d

  6. Positive COVID-19 test within previous 10d

  7. Chronic iron overload (including conditions such as hemochromatosis and betathalassemia major) or previous iron chelation therapy (including prior participationin DEFEAT-AKI)

  8. Known hypersensitivity to deferoxamine

  9. Taking prochlorperazine

  10. Severe hearing loss

  11. Pregnant or breastfeeding

  12. Prisoner

  13. Concurrent participation in another interventional research study in which theintervention has potential interaction with deferoxamine

  14. Surgery to be performed under conditions of circulatory arrest

  15. Receiving extracorporeal membrane oxygenation

  16. Durable ventricular assist device (VAD) prior to surgery (does not include Impelladevice or intra-aortic balloon pump)

  17. Any condition which, in the judgement of the investigator, might increase the riskto the patient

  18. Conflict with other research studies

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: Normal saline
Phase: 2
Study Start date:
April 13, 2021
Estimated Completion Date:
December 14, 2024

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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