Overview
Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
Status:
Recruiting
Recruiting
Trial end date:
2025-08-01
2025-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Brigham and Women's HospitalCollaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Treatments:
Deferoxamine
Criteria
Inclusion Criteria:1. Age ≥18 years
2. Undergoing coronary artery bypass graft and/or valve surgery with cardiopulmonary
bypass
3. AKI risk score ≥6 at the time of screening
4. Written informed consent from the patient or surrogate
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, 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
2. Advanced chronic kidney disease (eGFR <15 ml/min/1.73m2 or end-stage kidney disease
receiving RRT)
3. Hemoglobin <8 g/dL (closest value in the prior 3 months)
4. Fever (temperature ≥38⁰C) in the last 48h
5. Suspected or confirmed bacteremia, endocarditis, or pyelonephritis
6. Pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious etiology
reported on chest x-ray or CT scan in the last 7d
7. Positive COVID-19 test within previous 3 weeks
8. Chronic iron overload (including conditions such as hemochromatosis and beta
thalassemia major) or previous iron chelation therapy (including prior participation
in DEFEAT-AKI)
9. Known hypersensitivity to deferoxamine
10. Taking prochlorperazine
11. Severe hearing loss
12. Pregnant or breastfeeding
13. Prisoner
14. Concurrent participation in another interventional research study in which the
intervention has potential interaction with deferoxamine
15. Surgery to be performed under conditions of circulatory arrest
16. Receiving extracorporeal membrane oxygenation
17. Durable ventricular assist device (VAD) prior to surgery (does not include Impella
device or intra-aortic balloon pump)
18. Any condition which, in the judgement of the investigator, might increase the risk to
the patient
19. Conflict with other research studies