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NCT Number: NCT07749417

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Jianfan Cai

CONTACT

[email protected]

+86 15801601007

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. CSA-AKI and severe CSA-AKI

    Time frame: 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.

  2. Contrast-associated acute kidney injury

    Time frame: 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 outcomes

  1. Severe Acute Kidney Injury

    Time frame: 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.

  2. Progression of AKI Stage

    Time frame: 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.

  3. Acute Kidney Disease (AKD)

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

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

  4. Renal Replacement Therapy (RRT)

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

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

  5. All-cause and Cardiovascular Mortality

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

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

  6. Major Adverse Cardiovascular Events (MACE)

    Time frame: 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.

  7. New-onset Chronic Kidney Disease or CKD Progression

    Time frame: 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.

  8. Rate of Decline in Glomerular Filtration Rate

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

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

  9. Change in Glomerular Filtration Rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianfang Cai

CONTACT

[email protected]

+86 15801601007

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Establishment and Validation of an Early Warning Model for Acute Kidney Injury During the Perioperative Period of Cardiovascular Diseases.

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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