Perioperative Risk Assessment of Acute Kidney Injury Related to Pulmonary Endarterectomy Under Deep Hypothermic Circulatory Arrest
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Occurrence of Acute Kidney Injury (AKI) after Pulmonary Endarterectomy (PEA)
研究概览
简要总结
This study aims to assess the perioperative risk factors for acute kidney injury (AKI) in patients undergoing pulmonary endarterectomy (PEA) with deep hypothermic circulatory arrest (DHCA). By analyzing retrospective data (2016-2025) from approximately 240 PEA patients and prospectively enrolling 44 patients (2025-2027), we will identify clinical risk factors, establish and validate a comprehensive prediction model, and explore the dynamic characteristics and predictive value of novel biomarkers (e.g., NGAL, KIM-1). The goal is to improve early warning and management of PEA-related AKI, thereby enhancing patient outcomes.
详细描述
Background: PEA is the radical treatment for chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary artery sarcoma, requiring DHCA to ensure a bloodless surgical field. However, AKI occurs in 10-49% of PEA patients, significantly higher than neurological injury, leading to prolonged hospitalization and increased mortality. The risk factors and predictive biomarkers for PEA-related AKI remain unclear, highlighting the need for this research.
Study Design: A single-center, dual-cohort study including:
Retrospective Cohort: Patients who underwent PEA at China-Japan Friendship Hospital from 2016 to 2025. Data on baseline characteristics, intraoperative parameters (CPB/DHCA duration, perfusion pressure), postoperative renal function (based on KDIGO criteria), and outcomes (e.g., renal replacement therapy) will be collected to identify risk factors.
Prospective Cohort: Patients scheduled for PEA from 2025 to 2027. Clinical data and biological samples (blood/urine) will be collected at multiple time points (preoperatively, 2h/6h during CPB, 0h/24h/72h postoperatively) to measure biomarkers (NGAL, KIM-1, Scr, BUN). This cohort will validate the prediction model and assess biomarker performance.
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary artery sarcoma, and scheduled for or having undergone pulmonary endarterectomy (PEA) .
- •Aged 18 to 85 years . Underwent PEA using cardiopulmonary bypass (CPB) combined with deep hypothermic circulatory arrest (DHCA) technology .
- •Complete clinical data (including preoperative baseline data, intraoperative CPB/DHCA parameters, and postoperative respiratory, circulatory, and renal function data) .
- •Available renal function indicators at 3 months after surgery .
排除标准
- •Receiving preoperative maintenance renal replacement therapy . Complicated with severe liver failure, end-stage malignant tumors, or other diseases that affect short-term prognosis .
- •Missing key data (e.g., CPB/DHCA duration, postoperative 72-hour serum creatinine [Scr]) that cannot be supplemented .
结局指标
主要结局
Occurrence of Acute Kidney Injury (AKI) after Pulmonary Endarterectomy (PEA)
时间窗: Within 7 days after PEA surgery
Acute kidney injury is defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, which includes three stages based on serum creatinine (Scr) elevation and urine output reduction. Scr\>1.5 times baseline or ≥0.3 mg/dl increase, or urine output \<0.5 ml/kg/h for 6-12h
次要结局
- Recovery of Renal Function(1 months after surgery)
- Use of Renal Replacement Therapy (RRT) survey(Within 3 months after surgery)
- Changes in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 3 Months Postoperatively(3 months after surgery)
- duration of postoperative dialysis or continuous renal replacement therapy (CRRT).(Within 3 months after surgery)
- Progression to Chronic Kidney Disease (CKD) at 3 Months Postoperatively(3 months after surgery)
- Dynamic Changes of Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Kidney Injury Molecule-1 (KIM-1) and Their Correlation with AKI Occurrence and Severity(From preoperative to 72 hours postoperatively)
研究者
Li Fang Wang
Dr. Li Fang Wang
China-Japan Friendship Hospital