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Clinical Trials in China / NCT07811570
Recruiting Observational

Discovery and Validation of Biomarkers for CSA-AKI Risk Prediction

NCT07811570 · tracked via the Priya Life Science China tracker
Sponsor
China National Center for Cardiovascular Diseases
Phase
Observational
Started
2026-03-01
Last updated
2026-09-10

Condition(s) studied

CSA-AKIAcute Kidney InjuryCardiovascular SurgeryBiomarkers

Study summary

This study aims to discover and validate new biomarkers for predicting CSA-AKI before cardiovascular surgery.

Nested case-control studies embedded in prospective cohorts. Adult patients scheduled for cardiovascular surgery were continuously included. Blood/urine/stool samples and clinical data before and after contrast agent exposure and before and after cardiovascular surgery were collected, and the occurrence, progression and outcome of CSA-AKI events were dynamically monitored. Based on the exposure to contrast agents and the occurrence of CSA-AKI, two case-controls were constructed in the prospective cohort. In the construction of two case-controls, biomarkers were identified and validated by using multi-omics analysis techniques and machine learning techniques, etc.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 1\. Age no less than 18 years old; * 2\. Scheduled cardiovascular surgery is proposed; * 3\. Pre-angiography and preoperative serum creatinine \<354 μ mol/L; * 4\. Informed consent. Exclusion Criteria: * 1\. Women who have a pregnancy plan within one year, are pregnant, or are breastfeeding; * 2\. Patients who have severe side effects such as allergies to iodine contrast agents; * 3\. Patients with hyperthyroidism; * 4\. Those who had AKI before the contrast agent or within 2 weeks before the operation, or whose AKI has not been relieved after the operation; * 5\. Patients undergoing kidney transplantation, peritoneal dialysis, or hemodialysis treatment; * 6\. Patients with malignant tumors or those with an expected lifespan of less than 12 months; * 7\. Angiography or preoperative acute heart failure; * 8\. Patients who have a history of massive hemorrhage in the past 30 days or have contraindications to anticoagulant therapy.

Primary outcome measure(s)

  • The occurrence of CSA-AKI — The assessment will be conducted from the end of the surgery until the 7th day after the operation.
    CSA-AKI is defined as: serum creatinine (SCr) within 48 hours after cardiovascular surgery increases by ≥26.5 µmol/L compared with the baseline, or SCr increases by ≥ 50% times the baseline value within 7 days after surgery, or urine output is less than 0.5 mL/kg/h and persists for more than 6 hours.

Trial sites (1)

FacilityCityRegionStatus
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Center for Cardiovascular Diseases Beijing Beijing Municipality Recruiting

More China National Center for Cardiovascular Diseases trials in China

rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) Starting soon
Effectiveness of an AI-Enabled Stratified Management System for Premature Coronary Artery Disease Recruiting
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death Active, not recruiting
The Chinese Hypertrophic Cardiomyopathy Study(CHCS) Recruiting
Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy Recruiting

Other trials for the same condition

China Collaborative Study on Epidemiology of Acute Kidney Injury Recruiting
Acute Kidney Injury in Critically Ill Patients Enrolling by invitation
Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury Recruiting
Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery Starting soon
Phosphate-Containing Replacement Fluid for Patients Undergoing CRRT Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07811570 on ClinicalTrials.gov ↗ ← All trials in China