Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-13

Study Completion Date

2024-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Deferoxamine

Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours

Group Type EXPERIMENTAL

Deferoxamine

Intervention Type DRUG

Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours

Placebo

Normal saline (240mL) intravenous infusion over 12 hours

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline (240mL) intravenous infusion over 12 hours

Interventions

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Deferoxamine

Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours

Intervention Type DRUG

Normal saline

Normal saline (240mL) intravenous infusion over 12 hours

Intervention Type DRUG

Eligibility Criteria

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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 \<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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No