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临床试验/NCT07668830
NCT07668830已完成不适用

Association Between Preoperative Ankle-Brachial Index and Postoperative Renal Adverse Events in Patients With Acute Stanford Type A Aortic Dissection: A Single-Center Retrospective Cohort Study

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
516
试验地点
1
主要终点
Postoperative Acute Kidney Injury

研究概览

简要总结

This single-centre retrospective observational cohort study evaluated the association between preoperative cuff-derived ankle-brachial index (ABI) and postoperative acute kidney injury (AKI) in adults undergoing emergency repair of acute type A aortic dissection. Existing clinical data from patients treated at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024 were used. High ABI was defined as >1.40, and the reference ABI range was defined as >0.90 and ≤1.40. The primary outcome was creatinine-defined AKI within 7 postoperative days. Exploratory analyses examined whether the association between cumulative intraoperative mean arterial pressure exposure and AKI differed according to ABI phenotype. No intervention or treatment allocation was assigned by the study protocol.

详细描述

This is a single-centre retrospective observational cohort study using routinely collected electronic health records from adults undergoing emergency open repair of acute type A aortic dissection at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024. No study-specific intervention, treatment allocation, or additional clinical follow-up was performed.

The principal exposure was preoperative cuff-derived ankle-brachial index (ABI). ABI was calculated from routine four-limb oscillometric cuff pressures. Each ankle systolic pressure was divided by the higher brachial systolic pressure, and the higher of the two side-specific ABI values was used for patient classification. High ABI was defined as >1.40, and the reference ABI range was defined as >0.90 and ≤1.40. ABI was considered an indirect vascular phenotype marker rather than a direct measure of arterial stiffness or renal autoregulatory reserve.

The primary outcome was postoperative acute kidney injury (AKI) within 7 days, defined using serum creatinine-based Kidney Disease: Improving Global Outcomes criteria. Multivariable regression models were used to evaluate the association between high ABI and postoperative AKI after adjustment for relevant clinical and operative covariates.

Exploratory analyses assessed whether the association between cumulative intraoperative mean arterial pressure (MAP) burden and postoperative AKI differed according to ABI phenotype. Cumulative MAP burden below 65 and 80 mm Hg was evaluated. The candidate haemodynamic thresholds were informed in part by preliminary data exploration; these interaction analyses were therefore considered hypothesis-generating and were not intended to identify physiological or treatment thresholds.

研究设计

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

入排标准

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

入选标准

  • •Adults aged 18 years or older with acute type A aortic dissection.
  • •Underwent emergency open surgical repair at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February
  • •Routine preoperative four-limb cuff pressure measurements sufficient for calculation of ABI.
  • •Postoperative serum creatinine measurements sufficient for ascertainment of AKI.

排除标准

  • •Non-standard or aborted repair, or insufficient intraoperative haemodynamic recordings for the planned analyses.
  • •Preoperative estimated glomerular filtration rate <30 ml min-1 1.73 m-2, maintenance dialysis, or end-stage kidney disease.
  • •Severe preoperative heart failure, defined as cardiogenic shock, mechanical circulatory support, left ventricular ejection fraction <30%, or New York Heart Association class IV.
  • •Previous peripheral or aortic intervention affecting ABI interpretation.
  • •Imaging-confirmed renal or limb malperfusion.
  • •For patients with more than one potentially eligible repair during the same admission, only the first eligible repair was included.

研究组 & 干预措施

Reference Ankle-Brachial Index Group

Patients with acute type A aortic dissection who underwent emergency surgical repair and had a preoperative cuff-derived ABI >0.90 and ≤1.40.

干预措施: Preoperative Ankle-Brachial Index (Other)

High Ankle-Brachial Index Group

Patients with acute type A aortic dissection who underwent emergency surgical repair and had a preoperative cuff-derived ABI >1.40.

干预措施: Preoperative Ankle-Brachial Index (Other)

结局指标

主要结局

Postoperative Acute Kidney Injury

时间窗: Within 7 days after surgery

Postoperative acute kidney injury was defined according to serum creatinine-based Kidney Disease: Improving Global Outcomes criteria. Acute kidney injury was identified if serum creatinine increased by at least 0.3 mg/dL within 48 hours after surgery or increased to at least 1.5 times the baseline value within 7 days after surgery.

次要结局

  • Postoperative Acute Kidney Disease(Within 7 to 90 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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