Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Advanced chronic kidney disease (eGFR <15 ml/min/1.73m2 or end-stage kidney disease receiving RRT)
- •Hemoglobin <8 g/dL (closest value in the prior 3 months)
- •Fever (temperature ≥38⁰C) in the last 48h
- •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)
- •Known hypersensitivity to deferoxamine
- •Taking prochlorperazine
- •Severe hearing loss
- •Pregnant or breastfeeding
- •Concurrent participation in another interventional research study in which the intervention has potential interaction with deferoxamine
- •Surgery to be performed under conditions of circulatory arrest
- •Receiving extracorporeal membrane oxygenation
- •Durable ventricular assist device (VAD) prior to surgery (does not include Impella device or intra-aortic balloon pump)
- •Any condition which, in the judgement of the investigator, might increase the risk to the patient
- •Conflict with other research studies
研究组 & 干预措施
Placebo
Normal saline (240mL) intravenous infusion over 12 hours
干预措施: Normal saline (Drug)
Deferoxamine
Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
干预措施: Deferoxamine (Drug)
结局指标
主要结局
Acute Kidney Injury
时间窗: 7 days
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
次要结局
- Number of Participants With Major Adverse Kidney Events(7 days)
- Renal Tubular Injury(3 days)
- Number of Participants With Postoperative Myocardial Injury(2 days)
- Number of Participants With Atrial Fibrillation or Atrial Flutter(7 days)
- Number of Participants With Prolonged Mechanical Ventilation(24 hours)
- Time to Liberation From Vasoactive Medications(7 days)
- Number of Participants With Sepsis(7 days)
- Ventilator-free Days(28 days)
- ICU-free Days(28 days)
- Hospital-free Days(28 days)
研究者
David Leaf
Associate Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital