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RecruitingNCT07811570Updated Sep 10, 2026

Discovery and Validation of Biomarkers for CSA-AKI Risk Prediction

An observational study in CSA-AKI, Acute Kidney Injury and Cardiovascular Surgery, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by China National Center for Cardiovascular Diseases · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 168 studies in Acute Kidney Injury with a site in China — 46 open to participants now, 54 under way, 1 of them phase 3. Acute Kidney Injury · China.

Planned enrollment
31st of 105
1,500 · median 472
Started
2026
with 24 others
Observational
105 of 168
26 open now
Primary completion
2027-06
later than 37 of 53 live
Registered
162nd of 168
by date
Lead sponsor
4 of 168
China National Center for Cardiovascular Diseases

Among the 168 studies in Acute Kidney Injury with a site in China, this one is the 31st largest by planned enrollment of the 105 observational ones that give a count, is one of 25 that started in 2026, is one of 105 observational ones, reaches primary completion later than 37 of the 53 other live ones, and was the 162nd registered.

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 393 are open to participants now.

Browse Acute Kidney Injury studies →

Open to participants now

46 of the 168 studies in Acute Kidney Injury with a site in China are open now. Recruiting first, the newest first:

40 more — sign in →

All 46 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 230 Acute Kidney Injury studies recruiting now, 162 (70%) set no upper age limit and 35 (15%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 168 studies in Acute Kidney Injury with a site in China, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • CSA-AKI
  • Acute Kidney Injury
  • Cardiovascular Surgery
  • Biomarkers

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients scheduled for elective cardiovascular surgery were continuously included in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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. .

Exclusion criteria

Exclusion Criteria:

  • 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 to anticoagulant therapy.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: The assessment will be conducted from the end of the surgery until the 7th day after the operation.

Secondary outcomes

  1. 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.

    Time frame: The assessment will be conducted from the end of the surgery until the 7th day after the operation.

  2. 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.

    Time frame: From the preoperative period to 48 hours after the operation

  3. 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.

    Time frame: From the end of surgery through postoperative day 7

  4. 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.

    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.

  5. 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

    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

  6. 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

    Time frame: Postoperative day 8 to 90 days

  7. 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.

    Time frame: From the end of surgery to 1 year after surgery

  8. 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.

    Time frame: From baseline to 1 year after cardiac surgery

  9. 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.

    Time frame: Within 1 year after cardiac surgery

  10. 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.

    Time frame: Follow-up assessment was conducted from the end of the surgery until one year after the operation.

  11. MACE

    The composite endpoints that occurred within one year after the operation, including cardiovascular death, myocardial infarction, heart failure and stroke.

    Time frame: Follow-up assessment was conducted from the end of the surgery until one year after the operation.

07

Study locations

1 of 1 sites recruiting
  • Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases
    Beijing, Beijing Municipality 100037, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Jun 2027, 15 months after the start.

Of 350 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 15 months is below that.

Counting every sponsor, half of 365 studies reached it within 24 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2026
First posted
Sep 10, 2026
StartActual
Mar 1, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07811570
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Mar 1, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Jianfang Cai
Contact
caijfbj@126.com
+86 15801601007
View the source record on ClinicalTrials.gov ↗

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