Perioperative Transcutaneous Fluorescence Detection of GFR Trajectory for the Early Prediction and Diagnosis of CSA-AKI.

Sponsor
China National Center for Cardiovascular Diseases
Study ID
NCT07749417
Status
Recruiting
Apply to this trial

Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

brief summary：The goal of this observational study is to evaluate the value of perioperative transcutaneous fluorescence glomerular filtration rate (GFR) monitoring for the early prediction and diagnosis of cardiac surgery-associated acute kidney injury (CSA-AKI) and contrast-associated acute kidney injury(CA-AKI) in adult patients. The main questions it aims to answer are: Can perioperative GFR or peri-contast trajectories measured by a transcutaneous fluorescence monitoring system predict the development of CSA-AKI or CA-AKI before conventional diagnostic criteria are met? What changes in perioperative or peri-contast GFR trajectories are associated with the occurrence and severity of CSA-AKI or CA-AKI? Participants scheduled for cardiovascular surgery or contast-enhanced CT scan or PCI will undergo continuous perioperative transcutaneous GFR monitoring following intravenous administration of a fluorescent tracer. Clinical characteristics, perioperative or peri-contast hemodynamic data, laboratory measurements, imaging findings, and postoperative or post-contast outcomes will be collected to evaluate the predictive and diagnostic performance of perioperative or peri-contrast GFR trajectories for CSA-AKI or PC-AKI.

Key Dates

First listed
Aug 6, 2026
Start date
Jul 17, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
436 participants (estimated)

Arms

  • Arm: Determination of GFR trajectories after cardiovascular surgery or contrast agent exposure
    Perform GFR testing on patients who are scheduled for cardiovascular surgery or who are going to receive contrast agents to determine the GFR trajectory after the cardiovascular surgery or the contrast agent exposure.
  • Arm: The determination of the GFR trajectory for CSA-AKI or CA-AKI
    Perform GFR testing on patients with AKI related to cardiovascular surgery or contrast agents to determine their trajectory
  • Arm: Perioperative changes in GFR for the early prediction and diagnosis of CSA-AKI
    Incorporate adult patients who meet the inclusion and exclusion criteria and are scheduled for cardiovascular surgery, and monitor their perioperative changes in GFR through GFR testing to achieve early prediction and diagnosis of CSA-AKI.

Primary Outcome Measure

CSA-AKI and severe CSA-AKI [ Time Frame: Within 7 days after cardiovascular surgery ]

Central Contacts

Related Studies