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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07811583
Enrollment
70000
Registered
2026-09-10
Start date
2015-01-01
Completion date
2027-12-31
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Cardiovascular Surgery, CSA-AKI

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.

Interventions

None listed

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 1\. Age no less than 18 years old; * 2\. 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; * 3\. 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.

Exclusion criteria

* 1\. Lack of preoperative baseline creatinine; * 2\. Patients who developed AKI before surgery or whose AKI did not recover: The definition of AKI follows the KDIGO 2012 guideline; * 3\. Patients with preoperative creatinine levels exceeding 354umol/L or those in CKD stage 5.

Design outcomes

Primary

MeasureTime frameDescription
The occurrence of CSA-AKIThe assessment will be conducted from the end of the surgery until the 7th day after the operationCSA-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.

Secondary

MeasureTime frameDescription
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 operationAcute 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.
The occurrence of persistent acute kidney injury48 hours after the diagnosis of acute kidney injuryPersistent 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.
Renal replacement therapy or in-hospital deathFrom 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.
CSA-AKI as defined by the AKIN standardFrom the preoperative period to 48 hours after the operationCSA-AKI as defined by AKIN: that is, the increase of serum creatinine within 48 hours is \>26.5umol/L or \> 50% of the baseline;
New CKD or progression of existing CKDFrom the preoperative baseline assessment through 1 year after cardiac surgeryChronic kidney disease (CKD) is defined according to the KDIGO 2024 guidelines. CKD progression is defined as: an estimated decrease in glomerular filtration rate (eGFR) from baseline of more than 25%, or an average annual eGFR decrease rate of more than 5 ml/min/1.73m²

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026