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临床试验/NCT04776486
NCT04776486已完成不适用

Evaluation of Glomerular Filtration Rate Using Iohexol Plasma Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年9月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
GFR obtained by the iohexol clearance technique

研究概览

简要总结

Evaluation of glomerular filtration rate using iohexol plasma clearance in critically ill patients with augmented renal creatinine clearance

详细描述

Single center study in ICU patients with augmented renal clearance comparing glomerular filtration rate (GFR) as measured by iohexol plasma clearance to that measured by creatinine clearance. Primary objective is to compare the GFR estimates made by iohexol plasma clearance (as reference method) and creatinine clearance using Bland-Altman method.

Secondary objective are to compare GFR as measured by iohexol plasma clearance to that calculated with the most commonly used renal clearance estimating formulas (Cockcroft and Gault, MDRD and CKD-EPI ), evaluate clinical determinant of the observed differences and evaluate determinants of extracellular volume.

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

入选标准

  • ICU patient
  • 24h Creatinine clearance >130ml/min/1.73m2
  • Urinary catheterization
  • Affiliation to a social security scheme

排除标准

  • Pregnancy
  • CT-scan with contrast media infusion the day of inclusion
  • Documented allergy to contrast media
  • Patient under guardianship / curatorship
  • Patient benefiting from the "State Medical Assistance"

研究组 & 干预措施

Critically ill patients with augmented renal clearance

Experimental

ICU patients with estimated renal clearance over 130ml/min/1.73m2

干预措施: Iohexol (Drug)

结局指标

主要结局

GFR obtained by the iohexol clearance technique

时间窗: 6 hours

GFR as measured by iohexol plasma clearance to evaluate its concordance, by the Bland and Altman method, with that obtained by measuring the clearance of creatinine.

GFR obtained by the creatinine clearance technique

时间窗: 6 hours

GFR as measured by creatinine plasma clearance

次要结局

  • Plasmatic Levetiracetam dosing(6 hours)
  • Plasmatic Cefotaxim dosing(6 hours)
  • GFR calculated using the Cockroft-Gault equation(6 hours)
  • GFR calculated using the Modification of diet in renal disease (MDRD) formula(6 hours)
  • GFR calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation(6 hours)
  • Plasmatic Vancomycin dosing(6 hours)
  • Plasmatic Piperacillin dosing(6 hours)
  • Plasmatic Aminoglycoside dosing(6 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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