Fenoldopam for Prevention of Acute kidNey Injury in Patients With aCute coronarY Syndrome Undergoing Coronary Angiography and/or Percutaneous Coronary Intervention - The FANCY Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Contrast induced acute kidney injury
研究概览
简要总结
Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography.
The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial.
Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies.
Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy.
The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.
详细描述
Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography.
The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial.
Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies.
Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy.
The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Indication to urgent/emergency coronary angiography
- •Normal renal function (eGFR> 60 ml/min/1.73 m2)
- •Moderate or high Mehran's risk score for CIN (>11).
- •Able to understand and willing to sign the informed CF
排除标准
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
研究组 & 干预措施
standard saline infusion
standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure.
干预措施: standard saline infusion (Drug)
fenoldopam infusion
combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.
干预措施: standard saline infusion (Drug)
fenoldopam infusion
combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.
干预措施: fenoldopam infusion (Drug)
结局指标
主要结局
Contrast induced acute kidney injury
时间窗: 48 hour
Incidence of contrast induced acute kidney injury at 48 hour post-procedural control
次要结局
- Markers of kidney injury(48 hour)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza