Cardiovascular SurgeryNCT07330453
Cardiovascular Surgery Early Prediction System for AKI :CARDS-AKI Registry
An observational study of Cardiovascular Surgery, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
This multicenter, prospective study prospectively enrolled patients undergoing cardiovascular surgery. Detailed perioperative clinical data and biospecimens were collected at multiple time points. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Surgery
- What is being tested?
- Observation
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 31 Jul 2029
- How long will I take part?
- 2 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Fuwai Hospital, CAMS \& PUMC, Peking University People's Hospital; Guangdong People's Hospital; Fuwai Hospital Shenzhen (Sun Yat-sen Cardiovascular Hospital, Shenzhen); Huaxi Hospital, Sichuan University; Yantai Yuhuangding Hospital; Fuwai Centarl China Cardiovascular Hospital; Fuwai Yunnan Hospital, Academy of Medical Science; Yinzhou District Center for Disease Control and Prevention, Ningbo; Peking University First Hospital
Who may be able to join
- Age ≥ 18 years；
- Scheduled to undergo elective cardiac surgery；
- Able to complete baseline data collection and provide written informed consent.
Who cannot join
- Preoperative serum creatinine > 353 μmol/L, history of or currently receiving dialysis therapy.
- History of kidney transplantation.
- Presence of 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
Fuwai Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100444
Sheng Liu, 8613501331366, liusheng@fuwai.com
About this study
Official title: Early Prediction and Clinical Outcomes of Cardiovascular Surgery-Associated Acute Kidney Injury: A Prospective Multicenter Cohort Study
This multicenter, prospective study prospectively enrolled patients undergoing cardiovascular surgery. Detailed perioperative clinical data and biospecimens were collected at multiple time points. The primary aim is to develop an early warning model for postoperative acute kidney injury (AKI) by integrating clinical data and biomarkers. Additionally, through long-term follow-up, the study seeks to characterize outcome trajectories and establish a prognostic model for AKI patients.
This study addresses four key questions: 1) Integration of clinical information and biomarkers to develop an early predictive model for cardiac surgery-associated acute kidney injury (CSA-AKI); 2) Identification of risk factors for CSA-AKI occurrence; 3) Determinants of prognosis in patients with CSA-AKI; and 4) Enhanced prediction of near- and long-term clinical event risks in this patient population.
Read more
Participants will receive standard perioperative management. The study protocol includes the following procedures:(1) Clinical Data Collection: Comprehensive perioperative clinical data will be systematically recorded. (2) Biospecimen Sampling: Serial blood and urine samples will be obtained at predefined time points throughout the perioperative period. (3) In-Hospital Monitoring: Clinical outcomes will be continuously monitored during the hospital stay. (3) Post-discharge Follow-up: Participants will be assessed at regular intervals after discharge to track the occurrence of major adverse events.
These findings provide a foundational basis for the development of a data-driven early-warning system. Such a system is designed to facilitate the prompt identification of high-risk patients and enable the initiation of personalized treatment strategies, thereby potentially improving clinical outcomes and optimizing resource allocation
- Conditions
- Cardiovascular Surgery
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
As an observational study, patients' therapeutic approach will not be modified during the course of this research.
| Study group | Role | What they receive |
|---|---|---|
| Patients who did not develop acute kidney injury(AKI) after cardiovascular surgery | Not described Receives: Other: Observation | |
| Patients who developed AKI after cardiovascular surgery | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of post-operative acute kidney injury
Measured: From the end of surgery to 48 hours postoperative
Secondary outcomes (2)
The occurrence of adverse kidney events up to 2 years.
Measured: 2 years
The occurrence of adverse cardiovascular events up to 2 years.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start25 Dec 2025 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SurgeryStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- 5,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Liu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330453
- Sponsor's protocol ID
- 2025ZD0547500
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction and Clinical Outcomes of Cardiovascular Surgery-Associated Acute Kidney Injury: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07330453
- Acronym / sponsor ID
- 2025ZD0547500
- Conditions
- Cardiovascular Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 9 Jan 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 multicenter, prospective study prospectively enrolled patients undergoing cardiovascular surgery. Detailed perioperative clinical data and biospecimens were collected at multiple time points. The primary aim is to develop an early warning model for postoperative acute kidney injury (AKI) by integrating clinical data and biomarkers. Additionally, through long-term follow-up, the study seeks to characterize outcome trajectories and establish a prognostic model for AKI patients.
This study addresses four key questions: 1) Integration of clinical information and biomarkers to develop an early predictive model for cardiac surgery-associated acute kidney injury (CSA-AKI); 2) Identification of risk factors for CSA-AKI occurrence; 3) Determinants of prognosis in patients with CSA-AKI; and 4) Enhanced prediction of near- and long-term clinical event risks in this patient population.
Participants will receive standard perioperative management. The study protocol includes the following procedures:(1) Clinical Data Collection: Comprehensive perioperative clinical data will be systematically recorded. (2) Biospecimen Sampling: Serial blood and urine samples will be obtained at predefined time points throughout the perioperative period. (3) In-Hospital Monitoring: Clinical outcomes will be continuously monitored during the hospital stay. (3) Post-discharge Follow-up: Participants will be assessed at regular intervals after discharge to track the occurrence of major adverse events.
These findings provide a foundational basis for the development of a data-driven early-warning system. Such a system is designed to facilitate the prompt identification of high-risk patients and enable the initiation of personalized treatment strategies, thereby potentially improving clinical outcomes and optimizing resource allocation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who did not develop acute kidney injury(AKI) after cardiovascular surgery | – | Other: Observation |
| Patients who developed AKI after cardiovascular surgery | – | Other: Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Fuwai Hospital, CAMS \& PUMC, Peking University People's Hospital; Guangdong People's Hospital; Fuwai Hospital Shenzhen (Sun Yat-sen Cardiovascular Hospital, Shenzhen); Huaxi Hospital, Sichuan University; Yantai Yuhuangding Hospital; Fuwai Centarl China Cardiovascular Hospital; Fuwai Yunnan Hospital, Academy of Medical Science; Yinzhou District Center for Disease Control and Prevention, Ningbo; Peking University First Hospital
Key inclusion criteria (3 listed)
- Age ≥ 18 years；
- Scheduled to undergo elective cardiac surgery；
- Able to complete baseline data collection and provide written informed consent.
Key exclusion criteria (3 listed)
- Preoperative serum creatinine > 353 μmol/L, history of or currently receiving dialysis therapy.
- History of kidney transplantation.
- Presence of 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationAs an observational study, patients' therapeutic approach will not be modified during the course of this research. | Other | Patients who developed AKI after cardiovascular surgery, Patients who did not develop acute kidney injury(AKI) after cardiovascular surgery |
Primary outcome
The occurrence of post-operative acute kidney injury
Time frame: From the end of surgery to 48 hours postoperative
2 secondary outcomes
The occurrence of adverse kidney events up to 2 years.
Time frame: 2 years
The occurrence of adverse cardiovascular events up to 2 years.
Time frame: 2 years
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 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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 Cardiovascular Surgery, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 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: opening soon, as of the sponsor's last update on 9 Jan 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 Sheng Liu (8613501331366, liusheng@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of post-operative acute kidney injury (time frame: From the end of surgery to 48 hours postoperative). 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 9 Jan 2026.