Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury (DEFEAT-AKI)
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ClinicalTrials.gov Identifier: NCT04633889 |
Recruitment Status :
Recruiting
First Posted : November 18, 2020
Last Update Posted : November 23, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Kidney Injury | Drug: Deferoxamine Drug: Normal saline | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury |
Actual Study Start Date : | April 13, 2021 |
Estimated Primary Completion Date : | June 1, 2024 |
Estimated Study Completion Date : | August 1, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Deferoxamine
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
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Drug: Deferoxamine
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours |
Placebo Comparator: Placebo
Normal saline (240mL) intravenous infusion over 12 hours
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Drug: Normal saline
Normal saline (240mL) intravenous infusion over 12 hours |
- 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
- Renal tubular injury [ Time Frame: 3 days ]Urine levels of NGAL and KIM-1
- Major Adverse Kidney Events [ Time Frame: 7 days ]Increase in serum creatinine ≥100%, receipt of renal replacement therapy, or death within 7 days
- Postoperative myocardial injury [ Time Frame: 2 days ]Peak postoperative troponin I elevation >10 times the 99th percentile upper reference limit
- Atrial fibrillation or atrial flutter [ Time Frame: 7 days ]New onset postoperative atrial fibrillation or atrial flutter (patients with atrial fibrillation or atrial flutter at baseline will be excluded)
- Prolonged mechanical ventilation [ Time Frame: 24 hours ]Requirement for mechanical ventilation >24h postoperatively
- Vasoactive-Inotropic Score [ Time Frame: 24 hours ]Validated method for integrating all IV vasoactive medications and their doses on an hourly basis into a single measure
- Time to liberation from vasoactive medications [ Time Frame: 7 days ]Number of hours from time of incision to liberation from all IV vasoactive medications
- Sepsis [ Time Frame: 7 days ]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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633889
Contact: David E. Leaf, MD, MMSc | 9144190622 | deleaf@bwh.harvard.edu | |
Contact: Shahzad Shaefi, MD, MPH | 6178203570 | sshaefi@bidmc.harvard.edu |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Aranya Bagchi, MBBS abagchi@mgh.harvard.edu | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: David E. Leaf, MD, MMSc 914-419-0622 deleaf@bwh.harvard.edu | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Shahzad Shaefi, MD, MPH sshaefi@bidmc.harvard.edu |
Principal Investigator: | David E. Leaf, MD, MMSc | Brigham and Women's Hospital |
Responsible Party: | David Leaf, Assistant Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT04633889 |
Other Study ID Numbers: |
2020P003605 R01DK125786 ( U.S. NIH Grant/Contract ) |
First Posted: | November 18, 2020 Key Record Dates |
Last Update Posted: | November 23, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Acute Kidney Injury Wounds and Injuries Renal Insufficiency Kidney Diseases Urologic Diseases Deferoxamine |
Siderophores Iron Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |