Neutrophil gElatinase-associated Lipocalin alloWs Intensive treatMent Of cOntrast Induced Nephropathy in Patients With Urgent/Emergency Percutaneous Coronary Intervention
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
- Incidence of contrast induced nephropathy
研究概览
简要总结
Patients who undergo urgent/emergency coronary angiography can not receive any preventive treatment of contrast induced nephropathy. We tested the hypothesis that Neutrophil gelatinase-associated lipocalin (NGAL), a new biomarker predictive for AKI, allows early and effective treatment of contrast induced nephropathy in patients with urgent/emergency coronary angiography
详细描述
Background Patients who undergo urgent/emergency coronary angiography can not receive any preventive treatment of contrast induced nephropathy.
An acute kidney injury is generally detected too late to allow effective intervention in patients who undergo urgent/emergency coronary angiography.
Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy.
Purpose The primary objective of this study is to to test the hypothesis that a NGAL-driven early intensive strategy can reduce the occurrence of contrast induced nephropathy in patients with urgent/emergency coronary angiography
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 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 consent form
排除标准
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
研究组 & 干预措施
Intensive treatment group
Patients will receive high concentration sodium bicarbonate (3 ml/kg/h for 1 hour, then 1 ml/kg/h for 7 h) followed by i.v. saline for 48 h after PCI in case of abnormal NGAL findings
干预措施: Intensive treatment with sodium bicarbonate (Drug)
Standard treament group
Patients will receive i.v. 1 ml/kg/h saline infusion for 48 h after PCI in case of abnormal NGAL findings
干预措施: Standard treatment with saline infusion (Drug)
结局指标
主要结局
Incidence of contrast induced nephropathy
时间窗: Baseline and 48 hours after angiography
Absolute increase in serum creatinine equal to or greater than 0.5 mg/dL detected 48 hours after angiography as compared with baseline value
次要结局
- Post-angiographic changes in renal function parameters(Baseline and 48 hours after angiography)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza