Comparison of Agreement Between mGFR and tGFR in ICU Patients With Acute Kidney Injury
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
- 否
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
干预措施: transdermal GFR (Device)
研究者
Bin Du
Senior Consultant Physician;Professor
Peking Union Medical College Hospital
