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

NCT07749417 | Recruiting

• 1 other identifier: 2025-2844
• Study Type: observational
• Target: 436
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within 72 hours after contrast media administration

Secondary Outcomes (9)

• Severe Acute Kidney Injury

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

• Progression of AKI Stage

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

• Acute Kidney Disease (AKD)

  From 7 days to 90 days after AKI onset

• Renal Replacement Therapy (RRT)

  Within 90 days after cardiac surgery or contrast media administration

• All-cause and Cardiovascular Mortality

  Within 1 year after cardiac surgery or contrast media administration

Study Arms (3)

Determination of GFR trajectories after cardiovascular surgery or contrast agent exposure

Perform GFR testing on patients who are scheduled for cardiovascular surgery or who are going to receive contrast agents to determine the GFR trajectory after the cardiovascular surgery or the contrast agent exposure.

The determination of the GFR trajectory for CSA-AKI or CA-AKI

Perform GFR testing on patients with AKI related to cardiovascular surgery or contrast agents to determine their trajectory

Perioperative changes in GFR for the early prediction and diagnosis of CSA-AKI

Incorporate adult patients who meet the inclusion and exclusion criteria and are scheduled for cardiovascular surgery, and monitor their perioperative changes in GFR through GFR testing to achieve early prediction and diagnosis of CSA-AKI.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Jianfang Cai

CONTACT

+86 15801601007; caijfbj@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

CN (1)