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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

436 Participants
are grouped into 3 trial groups
Group A: Determination of GFR trajectories after cardiovascular surgery or contrast agent exposure
Group B: The determination of the GFR trajectory for CSA-AKI or CA-AKI
Group C: Perioperative changes in GFR for the early prediction and diagnosis of CSA-AKI

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 7 days after cardiovascular surgery
2

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.

Time frame
Within 72 hours after contrast media administration

Secondary outcomes

1

Severe Acute Kidney Injury

Incidence of severe acute kidney injury, defined as KDIGO stage 2 or stage 3 acute kidney injury.

Time frame
Within 7 days after cardiac surgery or within 72 hours after contrast media administration
2

Progression of AKI Stage

Progression of acute kidney injury severity according to the KDIGO staging criteria from the initial diagnosis during follow-up.

Time frame
From AKI diagnosis to 7 days after cardiac surgery or 72 hours after contrast media administration
3

Acute Kidney Disease (AKD)

Incidence of acute kidney disease, defined according to the Acute Disease Quality Initiative (ADQI) criteria.

Time frame
From 7 days to 90 days after AKI onset
4

Renal Replacement Therapy (RRT)

Requirement for renal replacement therapy, including intermittent hemodialysis or continuous kidney replacement therapy.

Time frame
Within 90 days after cardiac surgery or contrast media administration

Other outcomes

Sponsors and contacts

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