Randomized Controlled Trial of Ultra-Low Contrast Coronary Angiography During Acute Kidney Injury (AKI)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Change in incidence of Contrast Induced Nephropathy (CIN)
研究概览
简要总结
The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.
详细描述
The study is a non-inferiority open-label randomized controlled trial. Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Once indication for invasive coronary angiography is determined, patients will be randomized to immediate angiography or to delayed angiography after renal function stabilizes. Immediate angiography will be performed within 24 of enrollment. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.
Definitions: AKI is defined as an increase in serum creatinine by ≥50% from baseline within 7 days or an increase in serum creatinine by ≥0.3 mg/dl within 2 days. CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial.
排除标准
- •Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment.
- •Contraindication for invasive coronary angiography other than AKI.
- •Percutaneous coronary intervention is indicated and cannot be postponed by 7 days.
- •Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography).
- •Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography.
- •Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.
研究组 & 干预措施
Immediate intervention arm
Immediate angiography will be performed within 24 hours of enrollment. Omnipaque contrast will be administered. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.
干预措施: Angiography (Procedure)
Delayed intervention arm
Delayed angiography will be performed after kidney function stabilizes.
干预措施: Angiography (Procedure)
结局指标
主要结局
Change in incidence of Contrast Induced Nephropathy (CIN)
时间窗: Within 7 days
CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value. The investigators will measure the incidence of CIN by the increase in serum creatinine to see if the incidence will be the same in both arms whether the patient received the immediate angiography or if it was delayed until kidney function has been stabilized.
次要结局
- Incidence of earlier occurrence of CIN(Within 7 days)
- Incidence of renal replacement therapy at up to 7 days post-angiography(Within 7 days)