Early Prediction and Clinical Outcomes of Cardiovascular Surgery-Associated Acute Kidney Injury: A Prospective Multicenter Cohort Study
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
- 是
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
Sheng Liu
Principal Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
