NCT02050269已完成3 期
Measuring the Plasma Clearance of Iohexol to Estimate Glomerular Filtration Rate in Intensive Care Unit Patients: Preliminary Feasibility Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Plasma clearance of iohexol
研究概览
简要总结
The objective of this study is to assess the feasibility of estimating the clearance of iohexol as an indirect measure of glomerular filtration rate in patients with unstable renal function in the intensive care unit through analysis of rich iohexol plasma kinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years
- •Patient admitted to intensive care for less than 12 hours
- •Acute circulatory failure
- •Patient carrying an arterial catheter
- •Informed consent obtained
- •Affiliated to social security system
排除标准
- •Administration of iohexol the week before intensive care admission
- •Administration of iohexol expected within 24 hours of study entry
- •Known history of cutaneous immediate or delayed allergic reaction to the injection of the product
- •Indication for albumin transfusion within 24 hours of potential inclusion in the study
- •Pregnancy or breastfeeding in progress
- •Patient under guardianship or judicial protection known at the time of inclusion
- •Withdrawal of consent
- •Administration of iohexol outside the study within 24 hours after administration of iohexol in the context of the study
- •Administration of intravenous albumin in the 24 hours following administration of iohexol in the context of the study
研究组 & 干预措施
Iohexol
Experimental
injection of 5 ml of iohexol
干预措施: Iohexol (Drug)
结局指标
主要结局
Plasma clearance of iohexol
时间窗: 24 hours
次要结局
- Link between plasma iohexol clearance and kindney injury markers(24 hours)
- Comparaison of plasma iohexol clearance measured with 3 and 6 vs. 9 kinetic points(24 hours)
- Plasma clearance of iohexol in patients developping or not acute kidney injury(7 days)
- Link between plasma iohexol clearance and urinary metabolomic markers(24 hours)
- Link between injury and/or functional kidney dammage and subsequent acute kidney injury(7 days)
研究者
研究点 (3)
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