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Clinical Trials/NCT07632469
NCT07632469Not yet recruitingPhase 4

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

Bin Du0 sites50 target enrollmentStarted: June 8, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
50

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

intervention group

Experimental

Intervention: transdermal GFR (Device)

Investigators

Sponsor
Bin Du
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Bin Du

Senior Consultant Physician;Professor

Peking Union Medical College Hospital

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