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NCT07749417
Perioperative Transcutaneous Fluorescence Detection of GFR Trajectory for the Early Prediction and Diagnosis of CSA-AKI.
Conditions: Acute Kidney Injury
Sex: All
Ages: 18 Years – N/A
Enrollment: 436
Sponsor: China National Center for Cardiovascular Diseases
Location: Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases Beijing Beijing Municipality
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years old;
2. Specific inclusion criteria for the cohort:
* GFR trajectory characterization after cardiovascular surgery or Iodine contrast agent exposure: Patients scheduled for elective cardiovascular surgery or interventional cardiovascular surgery or CTA; ② GFR trajectory characterization of AKI: Patients with confirmed CSA-AKI or contrast-associated acute kidney injury (CA-AKI).
Exclusion Criteria:
1. Received renal replacement therapy before surgery or before contrast imaging, including kidney transplantation and regular dialysis;
2. Serum creatinine \> 353 μmol/L before surgery or before contrast imaging;
3. Patients with AKI who did not recover before surgery or before contrast imaging;
4. Patients with malignant tumors.
Source: ClinicalTrials.gov (NCT07749417). StuddyBuddy aggregates publicly available trial information.