Perioperative Transcutaneous Fluorescence Detection of GFR Trajectory for the Early Prediction and Diagnosis of CSA-AKI.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Establishment and Validation of an Early Warning Model for Acute Kidney Injury During the Perioperative Period of Cardiovascular Diseases.
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.
Primary outcome measures
- CSA-AKI and severe CSA-AKI [Time frame: Within 7 days after cardiovascular surgery]
- Contrast-associated acute kidney injury [Time frame: Within 72 hours after contrast media administration]
Secondary outcome measures (9)
- Severe Acute Kidney Injury [Time frame: Within 7 days after cardiac surgery or within 72 hours after contrast media administration]
- Progression of AKI Stage [Time frame: From AKI diagnosis to 7 days after cardiac surgery or 72 hours after contrast media administration]
- Acute Kidney Disease (AKD) [Time frame: From 7 days to 90 days after AKI onset]
- Renal Replacement Therapy (RRT) [Time frame: Within 90 days after cardiac surgery or contrast media administration]
- All-cause and Cardiovascular Mortality [Time frame: Within 1 year after cardiac surgery or contrast media administration]
- Major Adverse Cardiovascular Events (MACE) [Time frame: Within 1 year after cardiac surgery or contrast media administration]
- New-onset Chronic Kidney Disease or CKD Progression [Time frame: Within 1 year after cardiac surgery or contrast media administration]
- Rate of Decline in Glomerular Filtration Rate [Time frame: From baseline to 1 year after cardiac surgery or contrast media administration]
- Change in Glomerular Filtration Rate [Time frame: From baseline to 90 days after cardiac surgery or contrast media administration]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old;
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Nation — Beijing
Identifiers
NCT: NCT07749417 · 2025-2844