Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
Purpose
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.
Condition
- Acute Kidney Injury
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 10d 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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 |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital