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

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.

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Key information

Conditions

CSA-AKI Acute Kidney Injury 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

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. 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.

Treatment and study plan

Primary outcomes

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: 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 outcomes

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:
- Serum creatinine index: Serum creatinine rises to 2.0-2.9 times the baseline value.
- 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:
- 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).
- 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 injury

Time frame: 48 hours after the diagnosis of acute kidney injury

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.
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.
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;
New CKD or progression of existing CKD

Time frame: From the preoperative baseline assessment through 1 year after cardiac surgery

Chronic 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

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start: 2015
Primary completion: 2025
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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