Deferoxamine
DrugDeferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
NCT Number: NCT04633889
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 7 days
Composite outcome that includes any of the following:
Time frame: 3 days
Urine KIM-1 standardized to urine creatinine
Time frame: 7 days
Defined as an increase in serum creatinine ≥100%, receipt of renal replacement therapy, or death within 7 days
Time frame: 2 days
Defined as postoperative hs-cTnI concentration ≥ the 90th percentile of the cohort on either postoperative day 1 or 2.
Time frame: 7 days
Defined as new onset postoperative atrial fibrillation or atrial flutter (patients with atrial fibrillation or atrial flutter at baseline will be excluded)
Time frame: 24 hours
Defined as a requirement for mechanical ventilation >24h postoperatively
Time frame: 7 days
Number of hours from time of incision to liberation from all IV vasoactive medications
Time frame: 7 days
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: 28 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
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
28 minus the number of days hospitalized. Patients who die within 28 days will be assigned 0 hospital-free days.
Brigham and Women's Hospital
Other
Acronym: DEFEAT-AKI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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