Acute Kidney InjuryNCT07749417
Perioperative Transcutaneous Fluorescence Detection of GFR Trajectory for the Early Prediction and Diagnosis of CSA-AKI.
An observational study of Acute Kidney Injury, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 436 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2026to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
Jianfan Cai, +86 15801601007, caijfbj@126.com
About this study
Official title: Establishment and Validation of an Early Warning Model for Acute Kidney Injury During the Perioperative Period of Cardiovascular Diseases.
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
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 72 hours after contrast media administration
Secondary outcomes (9)
Severe Acute Kidney Injury
Incidence of severe acute kidney injury, defined as KDIGO stage 2 or stage 3 acute kidney injury.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 90 days after cardiac surgery or contrast media administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start17 Jul 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749417
- Sponsor's protocol ID
- 2025-2844
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Validation of an Early Warning Model for Acute Kidney Injury During the Perioperative Period of Cardiovascular Diseases.
- ClinicalTrials.gov ID
- NCT07749417
- Acronym / sponsor ID
- 2025-2844
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old;
- Specific inclusion criteria for the cohort:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianfang Cai (+86 15801601007, caijfbj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSA-AKI and severe CSA-AKI (time frame: Within 7 days after cardiovascular surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.