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NCT Number: NCT07418242

Prognostic Value of Novel Biomarkers 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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan hospital, Shanghai, Shanghai Municipality, China

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About this study

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), 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Adult patients were included in the study if they were scheduled for elective open chest cavity cardiac surgeries, with or without the use of cardiopulmonary bypass (CPB). Inclusion criteria required that patients undergoing surgery with CPB must have at least one AKI risk factor, whereas those undergoing surgery without CPB needed to have at least two AKI risk factors.

The AKI risk factors were as follows:

  • age >70 years;
  • 30 < estimated glomerular filtration rate (eGFR) <60 mL·min-1·1.73 m-2;
  • diabetes mellitus, proteinuria;
  • a history of congestive heart failure within the previous year;
  • a left ventricular ejection fraction of 40% or lower;
  • prior cardiac surgery;
  • combined coronary artery bypass/valve procedure;
  • urgent procedure;
  • preoperative intra-aortic balloon pump.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. AKI occurrence within 7 days

    Time frame: 7 days

    AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

Secondary outcomes

  1. Moderate and severe AKI occurrence within 7 days

    Time frame: 7 days

    Stage 2 and stage 3 AKI based on KDIGO criteria.

  2. AKI occurrence within 48 hours

    Time frame: 48 hours

    AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

  3. AKI occurrence within 3 days

    Time frame: 3 days

    AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

  4. Major adverse kidney events

    Time frame: Perioperative

    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.

  5. Receipt of renal replacement treatment

    Time frame: Perioperative

    Patients received renal replacement therapy after being diagnosed with AKI.

  6. Mortality

    Time frame: 30 days

    Mortality at 30 days

  7. length of stay in the ICU

    Time frame: Perioperative

    length of stay in the ICU

  8. Length of stay in the hospital

    Time frame: Perioperative

    Length of stay in the hospital

  9. The number of days of use and cumulative dose of vasoactive drugs

    Time frame: Perioperative

    The number of days of use and cumulative dose of vasoactive drugs during ICU stay.

  10. AKI on CKD

    Time frame: Perioperative

    Number of patients with CKD develop AKI after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Guo wei Tu, MD

CONTACT

[email protected]

86-021-64041990

Ying Su, MD

CONTACT

[email protected]

+86 021 64041990

Sponsors and collaborators

Lead sponsor

Guowei Tu

Other

Registry information

Official study title

Prognostic Value of Novel Biomarker on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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