CSA-AKINCT07811570
Discovery and Validation of Biomarkers for CSA-AKI Risk Prediction
An observational study of CSA-AKI and Acute Kidney Injury, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study aims to discover and validate new biomarkers for predicting CSA-AKI before cardiovascular surgery. Nested case-control studies embedded in prospective cohorts. Adult patients scheduled for cardiovascular surgery were continuously included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CSA-AKI, Acute Kidney Injury, Cardiovascular Surgery
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Jun 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective cardiovascular surgery were continuously included in the study.
Who may be able to join
- 1. Age no less than 18 years old;
- 2. Scheduled cardiovascular surgery is proposed;
- 3. Pre-angiography and preoperative serum creatinine <354 μ mol/L;
- 4. Informed consent.
Who cannot join
- 1. Women who have a pregnancy plan within one year, are pregnant, or are breastfeeding;
- 2. Patients who have severe side effects such as allergies to iodine contrast agents;
- 3. Patients with hyperthyroidism;
- 4. Those who had AKI before the contrast agent or within 2 weeks before the operation, or whose AKI has not been relieved after the operation;
- 5. Patients undergoing kidney transplantation, peritoneal dialysis, or hemodialysis treatment;
- 6. Patients with malignant tumors or those with an expected lifespan of less than 12 months;
- 7. Angiography or preoperative acute heart failure;
- 8. Patients who have a history of massive hemorrhage in the past 30 days or have contraindications to anticoagulant therapy.
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: Early Prediction and Diagnosis of CSA-AKI
This study aims to discover and validate new biomarkers for predicting CSA-AKI before cardiovascular surgery.
Nested case-control studies embedded in prospective cohorts. Adult patients scheduled for cardiovascular surgery were continuously included. Blood/urine/stool samples and clinical data before and after contrast agent exposure and before and after cardiovascular surgery were collected, and the occurrence, progression and outcome of CSA-AKI events were dynamically monitored. Based on the exposure to contrast agents and the occurrence of CSA-AKI, two case-controls were constructed in the prospective cohort. In the construction of two case-controls, biomarkers were identified and validated by using multi-omics analysis techniques and machine learning techniques, etc.
- Conditions
- CSA-AKI, Acute Kidney Injury, Cardiovascular Surgery, Biomarkers
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of CSA-AKI
CSA-AKI is defined as: serum creatinine (SCr) within 48 hours after cardiovascular surgery increases by ≥26.5 µmol/L compared with the baseline, or SCr increases by ≥ 50% times the baseline value within 7 days after surgery, or urine output is less than 0.5 mL/kg/h and persists for more than 6 hours.
Measured: The assessment will be conducted from the end of the surgery until the 7th day after the operation.
Secondary outcomes (11)
The occurrence of severe CSA-AKI(i.e. AKI stage 2 or 3)
Acute kidney injury at stage 2 or stage 3 as defined by the KDIGO 2012 guidelines.AKI stage 2 is defined as:meet any of the following conditions: 1. Serum creatinine index: Serum creatinine rises to 2.0-2.9 times the baseline value. 2. Urine volume index: Urine volume remains consistently below 0.5 mL/kg/h for more than 12 hours. AKI stage 3 is defined as: meeting any of the following conditions: 1. Serum creatinine index: Serum creatinine increases to 3.0 times or more of the baseline value; Or the serum creatinine level rises to ≥ 4.0 mg/dL (≥ 353.6 μmol/L); Or start renal replacement therapy (such as hemodialysis, peritoneal dialysis). 2. Urine volume index: Urine volume remains consistently below 0.3 mL/kg/h for more than 24 hours; Or anuria (urine output < 100 mL/ day) persists for 12 hours or more.
Measured: The assessment will be conducted from the end of the surgery until the 7th day after the operation.
CSA-AKI as defined by the AKIN standard
CSA-AKI as defined by AKIN: that is, the increase of serum creatinine within 48 hours is >26.5umol/L or > 50% of the baseline.
Measured: From the preoperative period to 48 hours after the operation
The occurrence of persistent acute kidney injury
Persistent acute kidney injury is defined as acute kidney injury that persists for more than 48 hours after its initial diagnosis, based on serum creatinine and/or urine output according to KDIGO criteria.
Measured: From the end of surgery through postoperative day 7
Renal replacement therapy or in-hospital death
Receiving any form of renal replacement therapy (such as continuous renal replacement therapy, intermittent hemodialysis, etc.) or any in-hospital death caused by any reason.
Measured: From the end of cardiac surgery until the date of first occurrence of renal replacement therapy or in-hospital death, whichever came first, assessed up to 1 year after cardiac surgery.
The length of stay in the ICU and the total length of stay
Record the total number of days the patient was admitted to the ICU and the total number of days of this hospitalization
Measured: The length of stay in the ICU:From ICU admission until ICU discharge, up to 3 months after surgery The total length of stay:From hospital admission until hospital discharge, up to 1 year after surgery
New-onset acute kidney disease (AKD）
According to the KDIGO guidelines, a state where renal function remains persistently abnormal (serum creatinine or urine output does not return to baseline) for more than 7 days but less than 90 days after the occurrence of acute kidney injury
Measured: Postoperative day 8 to 90 days
Major adverse cardiovascular events (MACE) within 1 year after surgery
The composite endpoints that occurred within 1 year after surgery included cardiovascular death, myocardial infarction, heart failure and stroke.
Measured: From the end of surgery to 1 year after surgery
Change in Estimated Glomerular Filtration Rate (eGFR)
The change in eGFR will be calculated as the difference between eGFR at 1 year after the index cardiovascular surgery and baseline eGFR, expressed in mL/min/1.73 m².
Measured: From baseline to 1 year after cardiac surgery
New CKD or progression of existing CKD
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
MAKE
Composite endpoints that occurred within one year after surgery, including: a > 50% decrease in eGFR from baseline, entry into end-stage renal disease (initiating maintenance dialysis or receiving kidney transplantation), or death related to kidney disease.
Measured: Follow-up assessment was conducted from the end of the surgery until one year after the operation.
MACE
The composite endpoints that occurred within one year after the operation, including cardiovascular death, myocardial infarction, heart failure and stroke.
Measured: Follow-up assessment was conducted from the end of the surgery until one year after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CSA-AKIStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811570
- Sponsor's protocol ID
- 2025-2950
- Status last verified
- Dec 2025
- First submitted
- 3 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction and Diagnosis of CSA-AKI
- ClinicalTrials.gov ID
- NCT07811570
- Acronym / sponsor ID
- 2025-2950
- Conditions
- CSA-AKI, Acute Kidney Injury, Cardiovascular Surgery, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Sep 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.
This study aims to discover and validate new biomarkers for predicting CSA-AKI before cardiovascular surgery.
Nested case-control studies embedded in prospective cohorts. Adult patients scheduled for cardiovascular surgery were continuously included. Blood/urine/stool samples and clinical data before and after contrast agent exposure and before and after cardiovascular surgery were collected, and the occurrence, progression and outcome of CSA-AKI events were dynamically monitored. Based on the exposure to contrast agents and the occurrence of CSA-AKI, two case-controls were constructed in the prospective cohort. In the construction of two case-controls, biomarkers were identified and validated by using multi-omics analysis techniques and machine learning techniques, etc.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective cardiovascular surgery were continuously included in the study.
Key inclusion criteria (4 listed)
- 1. Age no less than 18 years old;
- 2. Scheduled cardiovascular surgery is proposed;
- 3. Pre-angiography and preoperative serum creatinine <354 μ mol/L;
- 4. Informed consent.
Key exclusion criteria (8 listed)
- 1. Women who have a pregnancy plan within one year, are pregnant, or are breastfeeding;
- 2. Patients who have severe side effects such as allergies to iodine contrast agents;
- 3. Patients with hyperthyroidism;
- 4. Those who had AKI before the contrast agent or within 2 weeks before the operation, or whose AKI has not been relieved after the operation;
- 5. Patients undergoing kidney transplantation, peritoneal dialysis, or hemodialysis treatment;
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
The occurrence of CSA-AKI
Time frame: The assessment will be conducted from the end of the surgery until the 7th day after the operation.
CSA-AKI is defined as: serum creatinine (SCr) within 48 hours after cardiovascular surgery increases by ≥26.5 µmol/L compared with the baseline, or SCr increases by ≥ 50% times the baseline value within 7 days after surgery, or urine output is less than 0.5 mL/kg/h and persists for more than 6 hours.
11 secondary outcomes
The occurrence of severe CSA-AKI(i.e. AKI stage 2 or 3)
Time frame: The assessment will be conducted from the end of the surgery until the 7th day after the operation.
CSA-AKI as defined by the AKIN standard
Time frame: From the preoperative period to 48 hours after the operation
The occurrence of persistent acute kidney injury
Time frame: From the end of surgery through postoperative day 7
Renal replacement therapy or in-hospital death
Time frame: From the end of cardiac surgery until the date of first occurrence of renal replacement therapy or in-hospital death, whichever came first, assessed up to 1 year after cardiac surgery.
The length of stay in the ICU and the total length of stay
Time frame: The length of stay in the ICU:From ICU admission until ICU discharge, up to 3 months after surgery The total length of stay:From hospital admission until hospital discharge, up to 1 year after surgery
New-onset acute kidney disease (AKD）
Time frame: Postoperative day 8 to 90 days
Major adverse cardiovascular events (MACE) within 1 year after surgery
Time frame: From the end of surgery to 1 year after surgery
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: From baseline to 1 year after cardiac surgery
New CKD or progression of existing CKD
Time frame: Within 1 year after cardiac surgery
MAKE
Time frame: Follow-up assessment was conducted from the end of the surgery until one year after the operation.
MACE
Time frame: Follow-up assessment was conducted from the end of the surgery until one year after the operation.
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 10 Sep 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 CSA-AKI and 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 4 inclusion and 8 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 10 Sep 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?
The occurrence of CSA-AKI (time frame: The assessment will be conducted from the end of the surgery until the 7th day after the operation.). 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 10 Sep 2026.