- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07811583
Establishment of a Perioperative Dynamic Prediction Model for Cardiac Surgery-associated Acute Kidney Injury
2026년 9월 9일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (추정된)
70000
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
The cohort included adult patients who underwent cardiovascular surgery from 2015 to 2025 (Beijing) and from 2022 to 2025 (branch hospital).
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The occurrence of CSA-AKI
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The occurrence of severe CSA-AKI(i.e. AKI stage 2 or 3)
기간: 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:
AKI stage 3 is defined as: meeting any of the following conditions:
|
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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 1월 1일
기본 완료 (실제)
2025년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 8월 3일
QC 기준을 충족하는 최초 제출
2026년 9월 9일
처음 게시됨 (실제)
2026년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 9일
마지막으로 확인됨
2025년 12월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-GSP-TS-2
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