Discovery and Validation of Biomarkers for CSA-AKI Risk Prediction

NCT07811570 | Recruiting

• 1 other identifier: 2025-2950
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CSA-AKI; Acute Kidney Injury; Cardiovascular Surgery; Biomarkers

Outcome Measures

Primary Outcomes (1)

• The occurrence of CSA-AKI

  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.

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

Secondary Outcomes (11)

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

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

• CSA-AKI as defined by the AKIN standard

  From the preoperative period to 48 hours after the operation

• The occurrence of persistent acute kidney injury

  From the end of surgery through postoperative day 7

• Renal replacement therapy or in-hospital death

  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.

• The length of stay in the ICU and the total length of stay

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective cardiovascular surgery were continuously included in the study.

You may qualify if:

• \. Age no less than 18 years old;
• \. Scheduled cardiovascular surgery is proposed;
• \. Pre-angiography and preoperative serum creatinine \<354 μ mol/L;
• \. Informed consent.

You may not qualify if:

• \. Women who have a pregnancy plan within one year, are pregnant, or are breastfeeding;
• \. Patients who have severe side effects such as allergies to iodine contrast agents;
• \. Patients with hyperthyroidism;
• \. 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;
• \. Patients undergoing kidney transplantation, peritoneal dialysis, or hemodialysis treatment;
• \. Patients with malignant tumors or those with an expected lifespan of less than 12 months;
• \. Angiography or preoperative acute heart failure;
• \. Patients who have a history of massive hemorrhage in the past 30 days or have contraindications to anticoagulant therapy.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Jianfang Cai

CONTACT

+86 15801601007; caijfbj@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: September 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 10, 2026

Record last verified: 2025-12

Locations

CN (1)