Cardiac Surgery Associated - Acute Kidney InjuryNCT07418242
Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
An observational study of Cardiac Surgery Associated - Acute Kidney Injury and Critical Illness, run by Guowei Tu at 2 sites in China.
Trial summary
This project aims to detect novel biomarkers from preoperative and early postoperative serum and urine samples of patients to screen and analyze the risk factors for predicting adverse postoperative renal outcomes in high-risk patients in cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery Associated - Acute Kidney Injury, Critical Illness
- How many people
- 319 participants
- Where
- 2 sitesChina
- Study dates
- 23 Feb 2026to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All high-risk AKI patients who underwent cardiac surgery at Zhongshan Hospital Affiliated to Fudan University.CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality. The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%.
Who may be able to join
None listed.
Who cannot join
- pre-existing chronic kidney disease (preoperative estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2);
- previous RRT before cardiac surgery;
- present AKI at screening;
- a history of kidney transplant or other kidney diseases;
- known pregnancy;
- multiple operation during the hospital stay;
- being in a moribund state (with an anticipated likelihood of death within 48 hours).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhongshan hospital, Fudan university
Shanghai, Shanghai Municipality, 200030
Zhongshan hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Prognostic Value of Novel Biomarker on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
This project aims to detect novel biomarkers from preoperative and early postoperative serum and urine samples of patients to screen and analyze the risk factors for predicting adverse postoperative renal outcomes in high-risk patients in cardiac surgery.
Read the detailed description
This project will prospectively collect all high-risk individuals who underwent cardiac surgery, collect medical history, laboratory data and specimen test results, and test biomarkers in blood and urine specimens. Previously identified candidate biomarkers include the tumor necrosis factor-like weak inducer of apoptosis receptor (TWEAKR), galectin-9 (Gal-9), perilipin-2 (Plin2), CCL-20 and CCN family member 1, among others. The occurrence of postoperative AKI will be the primary endpoint of the study. The variable factors that can be used to predict and warn the main research endpoints at an early stage were screened through methods such as logistic regression, and their non-inferiority compared with traditional markers was tested. This study will facilitate early clinical identification and early warning of AKI, early implementation of preventive measures and intervention strategies, thereby improving the prognosis of patients and improve the overall safety and success rate of cardiac surgery.
- Being tested
- Standard care "bundle"
- Keywords
- Acute kidney injury, Biomarker, Poor outcome, AKI occurrence, Prognostic value, Cardiac Surgery Associated - Acute Kidney Injury
- Medical subject headings
- Critical Illness, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care "bundle"Other
The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline.
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI occurrence within 7 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Measured: 7 days
Secondary outcomes (7)
Moderate and severe AKI occurrence within 7 days
Stage 2 and stage 3 AKI based on KDIGO criteria.
Measured: 7 days
AKI occurrence within 3 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Measured: 3 days
Major adverse kidney events
MAKE at discharge MAKE was defined as the composite of≥25% loss in estimated glomerular filtration rate (eGFR), dialysis, or death.
Estimated GFR was calculated from serum creatinine using the MDRD equation.
Measured: Perioperative
Receipt of renal replacement treatment
Patients received renal replacement therapy after being diagnosed with AKI.
Measured: Perioperative
Mortality
Mortality at 30 days
Measured: 30 days
length of stay in the ICU
length of stay in the ICU
Measured: Perioperative
Length of stay in the hospital
Length of stay in the hospital
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start23 Feb 2026
- Primary completion31 May 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Associated - Acute Kidney InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guowei Tu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guowei Tu, Shanghai Zhongshan Hospital
- Investigators
- Zhe Luo, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418242
- Sponsor's protocol ID
- B2025-549
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2026
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Novel Biomarker on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT07418242
- Acronym / sponsor ID
- B2025-549
- Keywords
- Acute kidney injury, Biomarker, Poor outcome, AKI occurrence, Prognostic value, Cardiac Surgery Associated - Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Guowei TuUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 18 Feb 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 project aims to detect novel biomarkers from preoperative and early postoperative serum and urine samples of patients to screen and analyze the risk factors for predicting adverse postoperative renal outcomes in high-risk patients in cardiac surgery.
Detailed description
This project will prospectively collect all high-risk individuals who underwent cardiac surgery, collect medical history, laboratory data and specimen test results, and test biomarkers in blood and urine specimens. Previously identified candidate biomarkers include the tumor necrosis factor-like weak inducer of apoptosis receptor (TWEAKR), galectin-9 (Gal-9), perilipin-2 (Plin2), CCL-20 and CCN family member 1, among others. The occurrence of postoperative AKI will be the primary endpoint of the study. The variable factors that can be used to predict and warn the main research endpoints at an early stage were screened through methods such as logistic regression, and their non-inferiority compared with traditional markers was tested. This study will facilitate early clinical identification and early warning of AKI, early implementation of preventive measures and intervention strategies, thereby improving the prognosis of patients and improve the overall safety and success rate of cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All high-risk AKI patients who underwent cardiac surgery at Zhongshan Hospital Affiliated to Fudan University.CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality. The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- pre-existing chronic kidney disease (preoperative estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2);
- previous RRT before cardiac surgery;
- present AKI at screening;
- a history of kidney transplant or other kidney diseases;
- known pregnancy;
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 |
|---|---|---|
| Standard care "bundle"The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline. | Other | – |
Primary outcome
AKI occurrence within 7 days
Time frame: 7 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
7 secondary outcomes
Moderate and severe AKI occurrence within 7 days
Time frame: 7 days
AKI occurrence within 3 days
Time frame: 3 days
Major adverse kidney events
Time frame: Perioperative
Receipt of renal replacement treatment
Time frame: Perioperative
Mortality
Time frame: 30 days
length of stay in the ICU
Time frame: Perioperative
Length of stay in the hospital
Time frame: Perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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. This study is not recruiting at the moment.
Zhe Luo, MD study director
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery Associated - Acute Kidney Injury and Critical Illness, run by Guowei Tu at 2 sites 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 0 inclusion and 7 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: finished, as of the sponsor's last update on 18 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AKI occurrence within 7 days (time frame: 7 days). 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 18 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.