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

China National Center for Cardiovascular Diseases436 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

436

Conditions

Acute Kidney Injury

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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.

Time frame: Within 7 days after cardiovascular surgery

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

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

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

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

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

All-cause and Cardiovascular Mortality

Incidence of all-cause mortality and cardiovascular mortality during follow-up.

Time frame: Within 1 year after cardiac surgery or contrast media administration

Major Adverse Cardiovascular Events (MACE)

Composite incidence of major adverse cardiovascular events, including cardiovascular death, myocardial infarction, ischemic stroke, and hospitalization for heart failure.

Time frame: Within 1 year after cardiac surgery or contrast media administration

New-onset Chronic Kidney Disease or CKD Progression

Incidence of newly diagnosed chronic kidney disease or progression of pre-existing chronic kidney disease, based on KDIGO CKD criteria.

Time frame: Within 1 year after cardiac surgery or contrast media administration

Rate of Decline in Glomerular Filtration Rate

Annualized decline in estimated glomerular filtration rate (eGFR) during follow-up.

Time frame: From baseline to 1 year after cardiac surgery or contrast media administration

Change in Glomerular Filtration Rate

Change in glomerular filtration rate measured by transcutaneous fluorescence monitoring and/or estimated glomerular filtration rate compared with baseline.

Time frame: From baseline to 90 days after cardiac surgery or contrast media administration

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts