Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury (NCT04633889) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
United States320 participantsStarted 2021-04-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years
. Undergoing coronary artery bypass graft and/or valve surgery with cardiopulmonary bypass
. AKI risk score ≥6 at the time of screening
. Written informed consent from the patient or surrogate
. Hemoglobin \<8 g/dL (closest value in the prior 3 months)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2, which means it's still in a relatively early stage of testing — what does that mean for how much is currently known about whether deferoxamine is safe and effective for preventing kidney injury after heart surgery?
2The trial is no longer recruiting new patients, so I can't join it now — are there other ongoing trials or standard treatments aimed at protecting the kidneys during cardiac surgery that might be worth exploring for my situation?
3Deferoxamine is being tested here specifically to prevent acute kidney injury connected to cardiac surgery — how likely am I to develop this type of kidney injury given my particular surgery and health history, and is prevention something my care team is actively planning for?
4Since this is a prevention-focused trial rather than a treatment trial, how would the timing of deferoxamine around my surgery work, and is that kind of intervention something that could realistically fit into my surgical care plan?
5Are there any known risks or side effects of deferoxamine that my doctor thinks are especially relevant to my case, given that Phase 2 trials are still building a full picture of the drug's safety profile?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Suspected or confirmed bacteremia, endocarditis, or pyelonephritis
. Pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious etiology reported on chest x-ray or CT scan in the last 7d
. Positive COVID-19 test within previous 10d
. Chronic iron overload (including conditions such as hemochromatosis and beta thalassemia major) or previous iron chelation therapy (including prior participation in DEFEAT-AKI)