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临床试验/NCT07632469
NCT07632469尚未招募4 期

Comparison of Agreement Between mGFR and tGFR in ICU Patients With Acute Kidney Injury

Bin Du0 个研究点目标入组 50 人开始时间: 2026年6月8日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50

研究概览

简要总结

The goal of this study is to learn if the TGFR device (which uses telmapirazin to continuously measure real-time GFR) works to provide accurate and dynamic kidney function assessment in critically ill adults with acute kidney injury (AKI). It will also learn how tGFR compares with the gold standard measured GFR (mGFR) and other commonly used estimate methods. The main questions it aims to answer are:

  • Does tGFR show good agreement with mGFR over the 0-12 hour period in AKI patients?
  • How do tGFR, mGFR, 4-hour creatinine clearance, kinetic GFR (keGFR), and CKD-EPI eGFR compare across different AKI stages?
  • What are the bias and variability of each method over time?

Researchers will compare tGFR to mGFR (iohexol clearance) to see if tGFR is a reliable alternative for bedside, continuous GFR monitoring. They will also compare tGFR against 4-hour creatinine clearance, keGFR, and eGFR to assess consistency across AKI stages.

Participants will:

  • Wear a single-use tGFR sensor patch on the chest for continuous GFR monitoring
  • Receive iohexol injection for mGFR measurement (gold standard)
  • Provide blood and urine samples for 4-hour creatinine clearance and other tests
  • Undergo repeated GFR assessments over the 12-hour study period

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CU stay ≤ 72 hours;
  • meets KDIGO AKI criteria;
  • age 18-85 years;
  • able to complete blood/urine collection and monitoring

排除标准

  • prior history of CKD stage 4 or higher;
  • recent contrast agent exposure or kidney transplant history;
  • pregnancy or breastfeeding; expected survival < 24 hours.

研究组 & 干预措施

intervention group

Experimental

干预措施: transdermal GFR (Device)

研究者

发起方
Bin Du
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bin Du

Senior Consultant Physician;Professor

Peking Union Medical College Hospital

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