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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
320
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
Normal saline (240mL) intravenous infusion over 12 hours
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Acute Kidney Injury
Composite outcome that includes any of the following: 1. 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 2. Increase in serum creatinine ≥0.3 mg/dl within the first 48h 3. Increase in serum creatinine ≥50% within 7 days 4. Receipt of renal replacement therapy within 7 days
Time frame: 7 days
Renal Tubular Injury
Urine levels of KIM-1
Time frame: 3 days
Number of Participants With Major Adverse Kidney Events
Defined as an increase in serum creatinine ≥100%, receipt of renal replacement therapy, or death within 7 days
Time frame: 7 days
Number of Participants With Postoperative Myocardial Injury
Defined as postoperative hs-cTnI concentration ≥ the 90th percentile of the cohort on either postoperative day 1 or 2.
Time frame: 2 days
Number of Participants With Atrial Fibrillation or Atrial Flutter
Defined as new onset postoperative atrial fibrillation or atrial flutter (patients with atrial fibrillation or atrial flutter at baseline will be excluded)
Time frame: 7 days
Number of Participants With Prolonged Mechanical Ventilation
Defined as a requirement for mechanical ventilation \>24h postoperatively
Time frame: 24 hours
Time to Liberation From Vasoactive Medications
Number of hours from time of incision to liberation from all IV vasoactive medications
Time frame: 7 days
Number of Participants With Sepsis
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.
Time frame: 7 days
Ventilator-free Days
28 minus the number of days ventilated. Patients who die within 28 days will be assigned 0 ventilator-free days.
Time frame: 28 days
ICU-free Days
28 minus the number of days in the ICU. Patients who die within 28 days will be assigned 0 ICU-free days.
Time frame: 28 days
Hospital-free Days
28 minus the number of days hospitalized. Patients who die within 28 days will be assigned 0 hospital-free days.
Time frame: 28 days
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