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NCT Number: NCT04633889

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Undergoing coronary artery bypass graft and/or valve surgery with cardiopulmonary bypass
  • AKI risk score ≥6 at the time of screening
  • Written informed consent from the patient or surrogate

Exclusion criteria

  • 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, use most recent value in last 3 months)
  • Urine output ≤0.5 ml/kg/h x 6 consecutive hours (only assessed in patients with hourly monitoring via Foley catheter)
  • Receipt of renal replacement therapy (RRT) within 7d
  • Advanced chronic kidney disease (eGFR <15 ml/min/1.73m2 or end-stage kidney disease receiving RRT)
  • Hemoglobin <8 g/dL (closest value in the prior 3 months)
  • Fever (temperature ≥38⁰C) in the last 48h
  • Suspected or confirmed bacteremia, endocarditis, or pyelonephritis
  • Pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious etiology reported on chest x-ray or CT scan in the last 7d
  • Positive COVID-19 test within previous 10d
  • Chronic iron overload (including conditions such as hemochromatosis and beta thalassemia major) or previous iron chelation therapy (including prior participation in DEFEAT-AKI)
  • Known hypersensitivity to deferoxamine
  • Taking prochlorperazine
  • Severe hearing loss
  • Pregnant or breastfeeding
  • Prisoner
  • Concurrent participation in another interventional research study in which the intervention has potential interaction with deferoxamine
  • Surgery to be performed under conditions of circulatory arrest
  • Receiving extracorporeal membrane oxygenation
  • Durable ventricular assist device (VAD) prior to surgery (does not include Impella device or intra-aortic balloon pump)
  • Any condition which, in the judgement of the investigator, might increase the risk to the patient
  • Conflict with other research studies

Treatment and study plan

Deferoxamine

Drug

Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours

normal saline

Drug

Normal saline (240mL) intravenous infusion over 12 hours

Primary outcomes

  1. Acute Kidney Injury

    Time frame: 7 days

    Composite outcome that includes any of the following:

    • Urine output <0.5 ml/kg/h for ≥6 consecutive hours within the first 48h or until the Foley catheter is removed, whichever occurs first
    • Increase in serum creatinine ≥0.3 mg/dl within the first 48h
    • Increase in serum creatinine ≥50% within 7 days
    • Receipt of renal replacement therapy within 7 days

Secondary outcomes

  1. Renal Tubular Injury

    Time frame: 3 days

    Urine KIM-1 standardized to urine creatinine

  2. Number of Participants With Major Adverse Kidney Events

    Time frame: 7 days

    Defined as an increase in serum creatinine ≥100%, receipt of renal replacement therapy, or death within 7 days

  3. Number of Participants With Postoperative Myocardial Injury

    Time frame: 2 days

    Defined as postoperative hs-cTnI concentration ≥ the 90th percentile of the cohort on either postoperative day 1 or 2.

  4. Number of Participants With Atrial Fibrillation or Atrial Flutter

    Time frame: 7 days

    Defined as new onset postoperative atrial fibrillation or atrial flutter (patients with atrial fibrillation or atrial flutter at baseline will be excluded)

  5. Number of Participants With Prolonged Mechanical Ventilation

    Time frame: 24 hours

    Defined as a requirement for mechanical ventilation >24h postoperatively

  6. Time to Liberation From Vasoactive Medications

    Time frame: 7 days

    Number of hours from time of incision to liberation from all IV vasoactive medications

  7. Number of Participants With Sepsis

    Time frame: 7 days

    Defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction is defined as an acute increase in the total SOFA score ≥2 points consequent to the infection.

  8. Ventilator-free Days

    Time frame: 28 days

    28 minus the number of days ventilated. Patients who die within 28 days will be assigned 0 ventilator-free days.

  9. ICU-free Days

    Time frame: 28 days

    28 minus the number of days in the ICU. Patients who die within 28 days will be assigned 0 ICU-free days.

  10. Hospital-free Days

    Time frame: 28 days

    28 minus the number of days hospitalized. Patients who die within 28 days will be assigned 0 hospital-free days.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: DEFEAT-AKI

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Nov 18, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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