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Cardiac Complication After Vascular Surgery (CCVS)

2017年6月13日 更新者:Jowita Biernawska、Pomeranian Medical University Szczecin

The Reasons of Repolarization Disturbances Disclosure in Vascular Surgery

The vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Many of perioperative risk factors of cardiac complications are modifiable. The identification may help in the global perioperative risk reduction.

Aim: The aim of the study was an identification of the factors which may release clinically overt repolarization disturbances.

Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.

研究概览

详细说明

Vascular surgery is thought as the highest risk procedure in the context of cardiac complications. The range may include acute coronary syndrome, acute circulatory failure, severe arrhythmias, syncope and sudden cardiac death. The patient population is considered as a high risk, too. Popular calculators used for risk stratifications are based on preoperative patient's history and some general laboratory results. However, general status of the patient changes dynamically during vascular procedures leading to acquired increased risk. For this reason, sole preoperative risk prediction based on standard calculators is unsuitable and suboptimal. Advanced monitoring systems may record some temporary disturbances (e.g. ventricular repolarization disturbances), which may be asymptomatic. The clinical significance in postoperative risk prediction of such observations remains undefined. On the other hand, many of perioperative cardiac complications are caused by modifiable factors. The identification may help in the global perioperative risk reduction.

研究类型

观察性的

注册 (实际的)

100

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The study was conducted by the team from Department of Anaesthesiology, Intensive Care and Acute Poisoning of the tertiary teaching hospital at the Pomeranian Medical University in Szczecin, Poland.

描述

Inclusion Criteria:

  • adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure

Exclusion Criteria:

  • heart stimulation,
  • atrioventricular and intraventricular conduction defects,
  • atrial fibrillation recorded before of the study,
  • antiarrhythmic drug treatment (except beta-blockers),
  • unoptimal patient general status (uncontrolled diabetes, active infection)
  • reoperation
  • emergency operations

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
vascular surgery patients
  • clinically concealed repolarization disturbances during vascular surgery procedure
  • clinically disclosed cardiac complications during and after vascular surgery procedure
  • an elective "open" vascular surgery procedure
  • ECG Holter recording during the procedure and 24 hours after operation (continuous electrocardiographic tracing (digital Holter ECG monitor)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
cardiac complications
大体时间:up to 30 days after vascular procedure
cardiac complications according to European Society of Cardiology
up to 30 days after vascular procedure

次要结果测量

结果测量
措施说明
大体时间
cardiac complications
大体时间:during surgical procedure
cardiac complications according to European Society of Cardiology
during surgical procedure
cardiac complications
大体时间:one year
cardiac complications according to European Society of Cardiology
one year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jowita Biernawska, MD, PhD、Department of Anaesthesiology and Intensive Care of the Pomeranian Medical University in Szczecin, Poland.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年12月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2017年6月1日

研究注册日期

首次提交

2017年6月8日

首先提交符合 QC 标准的

2017年6月13日

首次发布 (实际的)

2017年6月15日

研究记录更新

最后更新发布 (实际的)

2017年6月15日

上次提交的符合 QC 标准的更新

2017年6月13日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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