Acute Kidney DiseaseNCT07482683
Predicting Post-Cardiac Surgery Acute Kidney Disease: A Machine Learning Approach
An observational study of Acute Kidney Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Renal injury after cardiac surgery is one of the common complications with high incidence rate, high risk of death and progression to chronic kidney disease (CKD). Previous evaluations of perioperative renal function mainly focused on acute kidney injury (AKI) related to cardiac surgery within seven days after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Disease
- How many people
- 820 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: Inpatients undergoing cardiac surgery at Fuwai Hospital
Who may be able to join
- Age ≥ 18 years;
- Undergoing coronary artery bypass grafting and/or heart valve surgery, with or without aortic surgery;
- Baseline serum creatinine level < 354 umol/L;
- Informed consent obtained.
Who cannot join
- Emergency surgery;
- Multiple surgeries or reoperation;
- End-stage kidney disease (ESKD), renal replacement therapy, or kidney transplantation;
- Occurrence of AKI within 1 week before surgery or unresolved AKI;
- Death within 1 week after surgery.
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
National Center for Cardiovascular Diseases
Beijing
Lili Liu, 86-010-88396533, lll9536@sina.com
About this study
Official title: Development and Validation of a Machine Learning-Based Risk Prediction Model for Acute Kidney Disease After Cardiac Surgery
Renal injury after cardiac surgery is one of the common complications with high incidence rate, high risk of death and progression to chronic kidney disease (CKD). Previous evaluations of perioperative renal function mainly focused on acute kidney injury (AKI) related to cardiac surgery within seven days after surgery. The newly proposed concept of acute kidney disease (AKD) in recent years refers to acute or subacute kidney injury lasting seven to ninety days. Research has found that AKD can occur after AKI or in patients without AKI, and the two are both related and independent of each other, possibly indicating different subtypes of kidney injury. AKD is not uncommon and is a more significant predictor of mortality and end-stage kidney disease (ESKD). Therefore, AKD may be an important window for identifying and managing high-risk patients after cardiac surgery. Due to limited research on AKD after cardiac surgery, the risk factors for AKD are currently unclear, and there are no clinically practical and effective risk stratification tools available. This study aims to establish a multimodal perioperative data platform through a retrospective cohort, and use machine learning methods to construct a risk prediction model for AKD after cardiac surgery. The accuracy and stability of the model will be validated in a prospective study cohort, and an online risk prediction and clinical decision-making tool will be developed to help clinicians quickly conduct personalized risk assessments and optimize diagnosis and treatment strategies, thereby improving patient prognosis and reducing medical costs.
- Conditions
- Acute Kidney Disease
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 |
|---|---|---|
| Adult patients undergoing coronary artery bypass grafting and/or heart valve surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with acute kidney disease after cardiac surgery Assessed by KDIGO guideline
Measured: within 90 days after cardiac surgery
acute kidney disease after cardiac surgery
Measured: within 90 days after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Mar 2026 (estimated)
- 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 Acute Kidney DiseaseStudies 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
- 820 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482683
- Sponsor's protocol ID
- 2025-I2M-C&T-B-027
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Machine Learning-Based Risk Prediction Model for Acute Kidney Disease After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07482683
- Acronym / sponsor ID
- 2025-I2M-C&T-B-027
- Conditions
- Acute Kidney Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Mar 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.
Renal injury after cardiac surgery is one of the common complications with high incidence rate, high risk of death and progression to chronic kidney disease (CKD). Previous evaluations of perioperative renal function mainly focused on acute kidney injury (AKI) related to cardiac surgery within seven days after surgery. The newly proposed concept of acute kidney disease (AKD) in recent years refers to acute or subacute kidney injury lasting seven to ninety days. Research has found that AKD can occur after AKI or in patients without AKI, and the two are both related and independent of each other, possibly indicating different subtypes of kidney injury. AKD is not uncommon and is a more significant predictor of mortality and end-stage kidney disease (ESKD). Therefore, AKD may be an important window for identifying and managing high-risk patients after cardiac surgery. Due to limited research on AKD after cardiac surgery, the risk factors for AKD are currently unclear, and there are no clinically practical and effective risk stratification tools available. This study aims to establish a multimodal perioperative data platform through a retrospective cohort, and use machine learning methods to construct a risk prediction model for AKD after cardiac surgery. The accuracy and stability of the model will be validated in a prospective study cohort, and an online risk prediction and clinical decision-making tool will be developed to help clinicians quickly conduct personalized risk assessments and optimize diagnosis and treatment strategies, thereby improving patient prognosis and reducing medical costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing coronary artery bypass grafting and/or heart valve surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients undergoing cardiac surgery at Fuwai Hospital
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Undergoing coronary artery bypass grafting and/or heart valve surgery, with or without aortic surgery;
- Baseline serum creatinine level < 354 umol/L;
- Informed consent obtained.
Key exclusion criteria (5 listed)
- Emergency surgery;
- Multiple surgeries or reoperation;
- End-stage kidney disease (ESKD), renal replacement therapy, or kidney transplantation;
- Occurrence of AKI within 1 week before surgery or unresolved AKI;
- Death within 1 week after surgery.
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
Number of Participants with acute kidney disease after cardiac surgery Assessed by KDIGO guideline
Time frame: within 90 days after cardiac surgery
acute kidney disease after cardiac surgery
Time frame: within 90 days after cardiac surgery
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 19 Mar 2026.
- Individual participant dataSharing planned: No
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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 Disease, 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 5 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: opening soon, as of the sponsor's last update on 19 Mar 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 Lili Liu (86-010-88396533, lll9536@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with acute kidney disease after cardiac surgery Assessed by KDIGO guideline (time frame: within 90 days after cardiac 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 19 Mar 2026; AzTrials last refreshed its copy on 4 Nov 2026.