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NCT Number: NCT07811570

Discovery and Validation of Biomarkers for CSA-AKI Risk Prediction

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.

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Key information

Conditions

CSA-AKI Acute Kidney Injury Biomarkers Cardiovascular Surgery Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Jianfan Cai

CONTACT

[email protected]

+86 15801601007

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. The occurrence of CSA-AKI

    Time frame: 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.

Secondary outcomes

  1. The occurrence of severe CSA-AKI(i.e. AKI stage 2 or 3)

    Time frame: The assessment will be conducted from the end of the surgery until the 7th day after the operation.

    Acute kidney injury at stage 2 or stage 3 as defined by the KDIGO 2012 guidelines.AKI stage 2 is defined as:meet any of the following conditions: 1. Serum creatinine index: Serum creatinine rises to 2.0-2.9 times the baseline value. 2. Urine volume index: Urine volume remains consistently below 0.5 mL/kg/h for more than 12 hours. AKI stage 3 is defined as: meeting any of the following conditions: 1. Serum creatinine index: Serum creatinine increases to 3.0 times or more of the baseline value; Or the serum creatinine level rises to ≥ 4.0 mg/dL (≥ 353.6 μmol/L); Or start renal replacement therapy (such as hemodialysis, peritoneal dialysis). 2. Urine volume index: Urine volume remains consistently below 0.3 mL/kg/h for more than 24 hours; Or anuria (urine output < 100 mL/ day) persists for 12 hours or more.

  2. CSA-AKI as defined by the AKIN standard

    Time frame: From the preoperative period to 48 hours after the operation

    CSA-AKI as defined by AKIN: that is, the increase of serum creatinine within 48 hours is >26.5umol/L or > 50% of the baseline.

  3. The occurrence of persistent acute kidney injury

    Time frame: From the end of surgery through postoperative day 7

    Persistent acute kidney injury is defined as acute kidney injury that persists for more than 48 hours after its initial diagnosis, based on serum creatinine and/or urine output according to KDIGO criteria.

  4. Renal replacement therapy or in-hospital death

    Time frame: From the end of cardiac surgery until the date of first occurrence of renal replacement therapy or in-hospital death, whichever came first, assessed up to 1 year after cardiac surgery.

    Receiving any form of renal replacement therapy (such as continuous renal replacement therapy, intermittent hemodialysis, etc.) or any in-hospital death caused by any reason.

  5. The length of stay in the ICU and the total length of stay

    Time frame: The length of stay in the ICU:From ICU admission until ICU discharge, up to 3 months after surgery The total length of stay:From hospital admission until hospital discharge, up to 1 year after surgery

    Record the total number of days the patient was admitted to the ICU and the total number of days of this hospitalization

  6. New-onset acute kidney disease (AKD）

    Time frame: Postoperative day 8 to 90 days

    According to the KDIGO guidelines, a state where renal function remains persistently abnormal (serum creatinine or urine output does not return to baseline) for more than 7 days but less than 90 days after the occurrence of acute kidney injury

  7. Major adverse cardiovascular events (MACE) within 1 year after surgery

    Time frame: From the end of surgery to 1 year after surgery

    The composite endpoints that occurred within 1 year after surgery included cardiovascular death, myocardial infarction, heart failure and stroke.

  8. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: From baseline to 1 year after cardiac surgery

    The change in eGFR will be calculated as the difference between eGFR at 1 year after the index cardiovascular surgery and baseline eGFR, expressed in mL/min/1.73 m².

  9. New CKD or progression of existing CKD

    Time frame: Within 1 year after cardiac surgery

    Incidence of newly diagnosed chronic kidney disease or progression of pre-existing chronic kidney disease, based on KDIGO CKD criteria.

  10. MAKE

    Time frame: Follow-up assessment was conducted from the end of the surgery until one year after the operation.

    Composite endpoints that occurred within one year after surgery, including: a > 50% decrease in eGFR from baseline, entry into end-stage renal disease (initiating maintenance dialysis or receiving kidney transplantation), or death related to kidney disease.

  11. MACE

    Time frame: Follow-up assessment was conducted from the end of the surgery until one year after the operation.

    The composite endpoints that occurred within one year after the operation, including cardiovascular death, myocardial infarction, heart failure and stroke.

Study contacts

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

Jianfang Cai

CONTACT

[email protected]

+86 15801601007

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Early Prediction and Diagnosis of CSA-AKI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 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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