Acute Kidney Injury
Conditions
Brief 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.
Interventions
None listed
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSA-AKI and severe CSA-AKI | Within 7 days after cardiovascular surgery | 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 | Within 72 hours after contrast media administration | 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
| Measure | Time frame | Description |
|---|---|---|
| Severe Acute Kidney Injury | Within 7 days after cardiac surgery or within 72 hours after contrast media administration | Incidence of severe acute kidney injury, defined as KDIGO stage 2 or stage 3 acute kidney injury. |
| Progression of AKI Stage | From AKI diagnosis to 7 days after cardiac surgery or 72 hours after contrast media administration | Progression of acute kidney injury severity according to the KDIGO staging criteria from the initial diagnosis during follow-up. |
| Acute Kidney Disease (AKD) | From 7 days to 90 days after AKI onset | Incidence of acute kidney disease, defined according to the Acute Disease Quality Initiative (ADQI) criteria. |
| Renal Replacement Therapy (RRT) | Within 90 days after cardiac surgery or contrast media administration | Requirement for renal replacement therapy, including intermittent hemodialysis or continuous kidney replacement therapy. |
| All-cause and Cardiovascular Mortality | Within 1 year after cardiac surgery or contrast media administration | Incidence of all-cause mortality and cardiovascular mortality during follow-up. |
| Major Adverse Cardiovascular Events (MACE) | Within 1 year after cardiac surgery or contrast media administration | Composite incidence of major adverse cardiovascular events, including cardiovascular death, myocardial infarction, ischemic stroke, and hospitalization for heart failure. |
| New-onset Chronic Kidney Disease or CKD Progression | Within 1 year after cardiac surgery or contrast media administration | Incidence of newly diagnosed chronic kidney disease or progression of pre-existing chronic kidney disease, based on KDIGO CKD criteria. |
| Rate of Decline in Glomerular Filtration Rate | From baseline to 1 year after cardiac surgery or contrast media administration | Annualized decline in estimated glomerular filtration rate (eGFR) during follow-up. |
| Change in Glomerular Filtration Rate | From baseline to 90 days after cardiac surgery or contrast media administration | Change in glomerular filtration rate measured by transcutaneous fluorescence monitoring and/or estimated glomerular filtration rate compared with baseline. |
Countries
China
Contacts
CONTACTJianfang Cai
Outcome results
None listed