Establishment of a Perioperative Dynamic Prediction Model for Cardiac Surgery-associated Acute Kidney Injury

NCT07811583 | Active Not Recruiting

• 1 other identifier: 2025-GSP-TS-2
• Study Type: observational
• Target: 70,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiac surgery-associated Acute Kidney Injury (CSA-AKI) is one of the most common complications after cardiovascular Surgery, with an incidence rate as high as 30-50%. CSA-AKI has many hazards, including significantly increasing the hospital stay of patients after surgery and greatly increasing medical costs. Moreover, it significantly raises the short-term and long-term mortality (by 3 to 8 times) and the risk of occurrence or aggravation of chronic kidney disease (CKD) in patients after surgery. These risks increase with the aggravation of CSA-AKI. Therefore, early prevention and treatment throughout the perioperative period of CSA-AKI is crucial for improving prognosis. Early prediction, especially preoperative prediction, is the prerequisite for the early prevention and treatment of CSA-AKI throughout the course. The aim of this study is to establish a dynamic prediction model for the entire perioperative period of CSA-AKI, with the expectation of improving the prediction and diagnosis of CSA-AKI for the development and validation of a prediction model based on a multicenter retrospective cohort. Using retrospective multimodal data of perioperative cardiovascular surgeries from hospitals such as Beijing, Central China, Yunnan and Fuwai Hospital in Shenzhen, and based on artificial intelligence technologies (such as machine learning), a CSA-AKI risk prediction model suitable for the entire perioperative period dynamics of various surgical types was constructed.

Conditions

CSA-AKI; Acute Kidney Injury; Cardiovascular Surgery

Outcome Measures

Primary Outcomes (1)

• The occurrence of CSA-AKI

  CSA-AKI is defined as: an increase of ≥26.5 µmol/L in serum creatinine (SCr) within 48 hours after cardiovascular surgery compared with the baseline, or an increase of ≥ 50% of the baseline value within 7 days after surgery.

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

Secondary Outcomes (5)

• 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

• The occurrence of persistent acute kidney injury

  48 hours after the diagnosis of acute kidney injury

• 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.

• CSA-AKI as defined by the AKIN standard

  From the preoperative period to 48 hours after the operation

• New CKD or progression of existing CKD

  From the preoperative baseline assessment through 1 year after cardiac 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

The cohort included adult patients who underwent cardiovascular surgery from 2015 to 2025 (Beijing) and from 2022 to 2025 (branch hospital).

You may qualify if:

• \. Age no less than 18 years old;
• \. Patients who underwent cardiovascular surgeries at Fuwai Hospital in Beijing from 2015 to 2025 and at Fuwai Hospitals in Central China, Yunnan and Shenzhen from 2022 to 2025;
• \. At least one blood creatinine test should be conducted within 48 hours after the operation, and at least two blood creatinine tests should be conducted within one week after the operation.

You may not qualify if:

• \. Lack of preoperative baseline creatinine;
• \. Patients who developed AKI before surgery or whose AKI did not recover: The definition of AKI follows the KDIGO 2012 guideline;
• \. Patients with preoperative creatinine levels exceeding 354umol/L or those in CKD stage 5.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

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

Study Design

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

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: September 10, 2026
• Study Start: January 1, 2015
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 10, 2026

Record last verified: 2025-12