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CSA-AKINCT07811583

Establishment of a Perioperative Dynamic Prediction Model for Cardiac Surgery-associated Acute Kidney Injury

An observational study of CSA-AKI and Acute Kidney Injury, run by China National Center for Cardiovascular Diseases.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Cardiac surgery-associated Acute Kidney Injury (CSA-AKI) is one of the most common complications after cardiovascular Surgery, with an incidence rate as high as 30-50%. CSA-AKI has many hazards, including significantly increasing the hospital stay of patients after surgery and greatly increasing medical costs. Read more about this study

Who is it for?
Ages 18 years and older
How many people
70,000 participants
Where
No sites listed yet
Study dates
1 Jan 2015to 31 Dec 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: The cohort included adult patients who underwent cardiovascular surgery from 2015 to 2025 (Beijing) and from 2022 to 2025 (branch hospital).

Who may be able to join

  • 1. Age no less than 18 years old;
  • 2. Patients who underwent cardiovascular surgeries at Fuwai Hospital in Beijing from 2015 to 2025 and at Fuwai Hospitals in Central China, Yunnan and Shenzhen from 2022 to 2025;
  • 3. At least one blood creatinine test should be conducted within 48 hours after the operation, and at least two blood creatinine tests should be conducted within one week after the operation.

Who cannot join

  • 1. Lack of preoperative baseline creatinine;
  • 2. Patients who developed AKI before surgery or whose AKI did not recover: The definition of AKI follows the KDIGO 2012 guideline;
  • 3. Patients with preoperative creatinine levels exceeding 354umol/L or those in CKD stage 5.

About this study

Cardiac surgery-associated Acute Kidney Injury (CSA-AKI) is one of the most common complications after cardiovascular Surgery, with an incidence rate as high as 30-50%. CSA-AKI has many hazards, including significantly increasing the hospital stay of patients after surgery and greatly increasing medical costs. Moreover, it significantly raises the short-term and long-term mortality (by 3 to 8 times) and the risk of occurrence or aggravation of chronic kidney disease (CKD) in patients after surgery. These risks increase with the aggravation of CSA-AKI. Therefore, early prevention and treatment throughout the perioperative period of CSA-AKI is crucial for improving prognosis. Early prediction, especially preoperative prediction, is the prerequisite for the early prevention and treatment of CSA-AKI throughout the course. The aim of this study is to establish a dynamic prediction model for the entire perioperative period of CSA-AKI, with the expectation of improving the prediction and diagnosis of CSA-AKI for the development and validation of a prediction model based on a multicenter retrospective cohort. Using retrospective multimodal data of perioperative cardiovascular surgeries from hospitals such as Beijing, Central China, Yunnan and Fuwai Hospital in Shenzhen, and based on artificial intelligence technologies (such as machine learning), a CSA-AKI risk prediction model suitable for the entire perioperative period dynamics of various surgical types was constructed.

Medical subject headings
Acute Kidney Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of CSA-AKI

    CSA-AKI is defined as: an increase of ≥26.5 µmol/L in serum creatinine (SCr) within 48 hours after cardiovascular surgery compared with the baseline, or an increase of ≥ 50% of the baseline value within 7 days after surgery.

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

Secondary outcomes (5)

  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.

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

  2. 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: 48 hours after the diagnosis of acute kidney injury

  3. 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.

  4. 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

  5. New CKD or progression of existing CKD

    Chronic kidney disease (CKD) is defined according to the KDIGO 2024 guidelines. CKD progression is defined as: an estimated decrease in glomerular filtration rate (eGFR) from baseline of more than 25%, or an average annual eGFR decrease rate of more than 5 ml/min/1.73m²

    Measured: From the preoperative baseline assessment through 1 year after cardiac surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start1 Jan 2015
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Retrospective
Enrolment
70,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811583
Sponsor's protocol ID
2025-GSP-TS-2
Status last verified
Dec 2025
First submitted
3 Aug 2026
Last updated
10 Sep 2026
Results posted
No

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.

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 3 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: under way, not looking for participants, 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT07811583.

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.

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