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临床试验/NCT07330453
NCT07330453尚未招募不适用

Early Prediction and Clinical Outcomes of Cardiovascular Surgery-Associated Acute Kidney Injury: A Prospective Multicenter Cohort Study

Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2025年12月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
5,000
试验地点
1
主要终点
The occurrence of post-operative acute kidney injury

研究概览

简要总结

This multicenter, prospective study prospectively enrolled patients undergoing cardiovascular surgery. Detailed perioperative clinical data and biospecimens were collected at multiple time points. The primary aim is to develop an early warning model for postoperative acute kidney injury (AKI) by integrating clinical data and biomarkers. Additionally, through long-term follow-up, the study seeks to characterize outcome trajectories and establish a prognostic model for AKI patients.

This study addresses four key questions: 1) Integration of clinical information and biomarkers to develop an early predictive model for cardiac surgery-associated acute kidney injury (CSA-AKI); 2) Identification of risk factors for CSA-AKI occurrence; 3) Determinants of prognosis in patients with CSA-AKI; and 4) Enhanced prediction of near- and long-term clinical event risks in this patient population.

Participants will receive standard perioperative management. The study protocol includes the following procedures:(1) Clinical Data Collection: Comprehensive perioperative clinical data will be systematically recorded. (2) Biospecimen Sampling: Serial blood and urine samples will be obtained at predefined time points throughout the perioperative period. (3) In-Hospital Monitoring: Clinical outcomes will be continuously monitored during the hospital stay. (3) Post-discharge Follow-up: Participants will be assessed at regular intervals after discharge to track the occurrence of major adverse events.

These findings provide a foundational basis for the development of a data-driven early-warning system. Such a system is designed to facilitate the prompt identification of high-risk patients and enable the initiation of personalized treatment strategies, thereby potentially improving clinical outcomes and optimizing resource allocation

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years;
  • Scheduled to undergo elective cardiac surgery;
  • Able to complete baseline data collection and provide written informed consent.

排除标准

  • Preoperative serum creatinine > 353 μmol/L, history of or currently receiving dialysis therapy.
  • History of kidney transplantation.
  • Presence of malignant tumors.

研究组 & 干预措施

Patients who did not develop acute kidney injury(AKI) after cardiovascular surgery

干预措施: Observation (Other)

Patients who developed AKI after cardiovascular surgery

干预措施: Observation (Other)

结局指标

主要结局

The occurrence of post-operative acute kidney injury

时间窗: From the end of surgery to 48 hours postoperative

次要结局

  • The occurrence of adverse kidney events up to 2 years.(2 years)
  • The occurrence of adverse cardiovascular events up to 2 years.(2 years)

研究者

发起方
Chinese Academy of Medical Sciences, Fuwai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng Liu

Principal Investigator

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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