mGFR vs tGFR in AKI

ConditionsAKIGFR
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBin Du

About this trial

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

Eligibility criteria

Qualifiers

CU stay ≤ 72 hours;

meets KDIGO AKI criteria;

age 18-85 years;

able to complete blood/urine collection and monitoring

Disqualifiers

prior history of CKD stage 4 or higher;

anuria;

recent contrast agent exposure or kidney transplant history;

pregnancy or breastfeeding; expected survival < 24 hours.

Trial design

Treatments tested in this trial

  • transdermal GFR

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Bin Du

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution