INtravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal functiOn (INCARO) - a Multicentre, Open-label, Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 994
- 试验地点
- 6
- 主要终点
- Mortality or renal replacement therapy
研究概览
简要总结
Computer tomography (CT) is the primary imaging option for acute abdominal pain in adults. Intravenous (IV) contrast media is used to improve the CT quality. In patients with impaired renal function, post-contrast acute kidney injury (PC-AKI) has remained a significant concern. Modern retrospective studies have shown no association between worsened baseline renal function and IV-contrast CT. However, no randomised controlled trial has been done to conclude this. The INCARO (INtravenous Contrast computed tomography versus native computed tomography in patients with acute Abdomen and impaired Renal functiOn) trial is a multicentre, open-label, parallel group, superiority, individually randomised controlled trial comparing IV-contrast enhanced CT to native CT in patients with impaired renal function. Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2 are included in the study. The primary outcome is a composite outcome of all-cause mortality or renal replacement therapy within 90 days from CT.
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
- None
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
- •Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2
排除标准
- •Age less than 18 years
- •Pregnancy
- •eGFR less than 15 or more than 45 ml/min/1.73 m2
- •Renal replacement therapy within 30 days prior enrolment
- •CT with IV contrast less than 72 hours prior enrolment
- •Suspicion of vascular occlusion, dissection or bleeding (i.e. need for IV-contrast)
- •CT needed without IV-contrast to detect or rule out ureteral stone
- •IV contrast allergy
- •Inability to give written consent.
结局指标
主要结局
Mortality or renal replacement therapy
时间窗: Within 90 days from CT
A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients)
次要结局
- Acute kidney injury (AKI) grade(Within 72 hours after CT)
- Any organ failure(48 hours after CT)
- Alive and hospital-free(Within 90 days after CT)
- Time from CT to definitive treatment(During hospital stay estimated on average 7 days)
研究者
Ville Sallinen
Adj. Prof., Consultant, Clinical researcher
Helsinki University Central Hospital