Dapagliflozin in the Prevention of Post-Coronary Intervention Acute Kidney Injury
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
To compare the incidence of acute kidney injury (AKI) post percutaneous coronary intervention (PCI) in a Dapagliflozin treated group versus a group managed with the usual standard of care.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or more.
- •Scheduled/non-emergent Percutaneous coronary intervention (PCI).
- •Post-index procedure Staged PCI with at least 14 days from contrast exposure.
- •Patient can fully understand the study information and sign informed consent.
排除标准
- •Cardiogenic shock /need for inotrope or mechanical pump support.
- •Acute kidney injury as defined by KDIGO criteria (<4 weeks) prior to PCI.
- •End-Stage Renal Disease prior to PCI (On renal replacement therapy).
- •Diabetes Mellitus type
- •Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose >400 mg/dl).
- •ST-segment elevation Myocardial Infarction undergoing index PCI.
- •Active Genitourinary infection.
- •Diagnostic Left Heart Catheterization without PCI.
- •Patients undergoing zero contrast PCI.
- •Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization.
- •Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe).
- •Patients with Acute Heart Failure admission < 30 days prior to PCI.
- •Intercurrent illness resulting in volume depletion and hypotension (MAP<60 mmHg).
- •Patients with a kidney transplant.
- •Any contrast exposure within 14 days.
- •Patients with estimated glomerular filtration rate (eGFR) < 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling).
- •Patients with an active intrinsic inflammatory or autoimmune renal pathology.
- •Women of child bearing age (<50 years old).
- •Prison Inmates
研究组 & 干预措施
Dapagliflozin arm
Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI.
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
Acute Kidney Injury
时间窗: Within 7 days.
According to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 definition: increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline which is known or presumed to have occurred within the prior 7 days. We will measure Urine Neutrophil Gelatinase-associated Lipocalin (UNGAL) at least 6 hours post-PCI and Serum Creatinine at follow up within 7 days.
次要结局
- Length of hospital stay(7 days)
- Incidence of genitourinary infections(7 days)
研究者
Gregg Pressman
Staff Cardiologist and Director of Academics, Cardiology
Albert Einstein Healthcare Network