About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old;
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).
Disqualifiers
Received renal replacement therapy before surgery or before contrast imaging, including kidney transplantation and regular dialysis;
Serum creatinine > 353 μmol/L before surgery or before contrast imaging;
Patients with AKI who did not recover before surgery or before contrast imaging;
Patients with malignant tumors.
Trial population
Adult patients undergoing cardiovascular surgery or receiving iodinated contrast media who are at risk of acute kidney injury (AKI), as well as patients diagnosed with cardiac surgery-associated acute kidney injury (CSA-AKI) or contrast-associated acute kidney injury (CA-AKI), will be prospectively enrolled. Participants will undergo perioperative or peri-procedural transcutaneous glomerular filtration rate (GFR) monitoring to evaluate GFR trajectories for the early prediction and diagnosis of AKI.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
CSA-AKI and severe CSA-AKI
Incidence of cardiac surgery-associated acute kidney injury (CSA-AKI), defined according to the KDIGO criteria based on postoperative changes in serum creatinine and incidence of severe cardiac surgery-associated acute kidney injury, defined as KDIGO Stage 2 or Stage 3 acute kidney injury.
Contrast-associated acute kidney injury
Incidence of contrast-associated acute kidney injury, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria based on changes in serum creatinine following contrast media administration.
Secondary outcomes
Severe Acute Kidney Injury
Incidence of severe acute kidney injury, defined as KDIGO stage 2 or stage 3 acute kidney injury.
Progression of AKI Stage
Progression of acute kidney injury severity according to the KDIGO staging criteria from the initial diagnosis during follow-up.
Acute Kidney Disease (AKD)
Incidence of acute kidney disease, defined according to the Acute Disease Quality Initiative (ADQI) criteria.
Renal Replacement Therapy (RRT)
Requirement for renal replacement therapy, including intermittent hemodialysis or continuous kidney replacement therapy.
Sponsors and contacts
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