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Completed
NCT04633889
Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
Conditions: Acute Kidney Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 320
Sponsor: Brigham and Women's Hospital
Location: Massachusetts General Hospital Boston Massachusetts
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 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 \
Source: ClinicalTrials.gov (NCT04633889). StuddyBuddy aggregates publicly available trial information.