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

9. september 2026 opdateret af: China National Center for Cardiovascular Diseases

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

70000

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
The occurrence of CSA-AKI Tidsramme: 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.	The assessment will be conducted from the end of the surgery until the 7th day after the operation

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
The occurrence of severe CSA-AKI(i.e. AKI stage 2 or 3) Tidsramme: 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 assessment will be conducted from the end of the surgery until the 7th day after the operation
The occurrence of persistent acute kidney injury Tidsramme: 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.	48 hours after the diagnosis of acute kidney injury
Renal replacement therapy or in-hospital death Tidsramme: 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.	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 Tidsramme: 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;	From the preoperative period to 48 hours after the operation
New CKD or progression of existing CKD Tidsramme: 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	From the preoperative baseline assessment through 1 year after cardiac surgery

Samarbejdspartnere og efterforskere

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Sponsor

China National Center for Cardiovascular Diseases

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2015

Primær færdiggørelse (Faktiske)

31. december 2025

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

3. august 2026

Først indsendt, der opfyldte QC-kriterier

9. september 2026

Først opslået (Faktiske)

10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)