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临床试验/NCT05647486
NCT05647486已完成不适用

Predictors of 30-day Postoperative Outcome After Elective Endovascular Abdominal Aortic Aneurysm Repair

University of Thessaly1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2016年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
322
试验地点
1
主要终点
Number of patients with major adverse cardiovascular events

研究概览

简要总结

This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics

详细描述

The study included 322 consecutive AAA patients treated electively with EVAR from March 2016 to February 2019 at a tertiary referral center.

Early follow-up with clinical and laboratory evaluation took place at the 30rd day post-operatively. Any adverse event, such as major adverse cardiovascular events (MACE), post-implantation syndrome (PIS), acute kidney injury (AKI), and deaths of any cause were recorded.

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

入选标准

  • Only patients managed with EVAR using standard bifurcated devices in elective setting were included.

排除标准

  • Patients treated for ruptured, symptomatic, inflammatory or infectious AAA were excluded. Furthermore, any patient needing complex endovascular repair of the proximal landing zone was considered ineligible. Additional exclusion criteria were the presence of any trauma or surgery within two months before EVAR, any autoimmune or systemic inflammatory disease and any malignancy. Of note, any patient with clinical or laboratory signs of infection before the scheduled operation was not offered an EVAR until a complete resolution of the infection was confirmed via a clinical, laboratory and/or imaging evaluation.

结局指标

主要结局

Number of patients with major adverse cardiovascular events

时间窗: 30rd day post-operatively

Number of participants with major adverse cardiovascular events

Number of patients with acute kidney injury

时间窗: 30rd day post-operatively

Number of participants with acute kidney injury according to the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria

Number of patients with post-implantation syndrome

时间窗: 30rd day post-operatively

Number of participants with post-implantation syndrome SIRS, without any apparent sign of infection

Deaths of any cause

时间窗: 30rd day post-operatively

Number of participants who died from any cause

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Arnaoutoglou

Professor of Anesthesiology

University of Thessaly

研究点 (1)

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