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临床试验/NCT02570607
NCT02570607已完成不适用

Relevance of Preoperative BNP as a Biomarker of Postoperative Cardiovascular Complications in Major Non-cardiac Adult Surgery

Centre Hospitalier Universitaire de Nice0 个研究点目标入组 200 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
主要终点
occurrence of a complication or cardiovascular events

研究概览

简要总结

BNP is a hormone that predicts preoperatively the occurrence of postoperative cardiovascular complications. In practice, the problem is that the practitioner don't know the most opportune moment for the preoperative sample or what threshold used to classify our patient in patients at risk of cardiovascular complication or not at risk.

The purpose of this study is to determine the best time to dose the preoperative BNP with a specific threshold being associated with it allowing the practitioner to assess more accurately the post operative cardiovascular risk patients and possibly offer them strategies taking different load.

The BNP will be dosed during the anesthetic consultation and the day of surgery in immediate preoperative operating room. Post-operative cardiovascular complications will be collected during hospitalization of the patient and by telephone contact on the 28th day, 90th day and 6th postoperative months.

The investigator then establish the threshold BNP most informative for both sampling times and then compare them to determine the most discriminating dosage and thus the most appropriate time for the determination of BNP.

详细描述

The morbidity and mortality of non-cardiac major surgery is mainly due to cardiovascular complications. BNP is a hormone for predicting preoperatively the occurrence of these complications. Widely used in cardiac surgery, it is not routinely used in non-cardiac major surgery. His interest in this type of surgery has yet been proven by numerous studies.

In practice, the problem with this biomarker is the pratitioner do not know the most opportune moment for the preoperative dose or what threshold used to classify our patient patients at risk of cardiovascular complication or not at risk.

Indeed, recent literature reviews are used to highlight the fact that existing studies on the subject using each method or BNP assay devices and heterogeneous preoperative dosing of different times or even BNP not exactly specified. It thus appears as many different levels of BNP. Practitioners did not then know when dosing the BNP and what threshold is based.

The purpose of this study is to determine the best time to dose the preoperative BNP with a specific threshold being associated with it allowing the practitioner to assess more accurately the post operative cardiovascular risk patients and possibly offer them strategies taking different load.

The BNP will be dosed during the anesthetic consultation and the day of surgery in immediate preoperative operating room. Post-operative cardiovascular complications will be collected during hospitalization of the patient and by telephone contact on the 28th day, 90th day and 6th postoperative months.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major patients who was not opposed to one additional sample
  • Who have to undergoing moderate or high cardiovascular risk non-ambulatory scheduled surgery with the exception of cardiac surgery
  • With predictable delay between the preoperative evaluation and the surgery > 15 days

排除标准

  • Moderate cardiovascular risk surgeries (1-5%):
  • Carotid Endarterectomy
  • Surgery of the Head and Neck
  • Thoracic surgery and intraperitoneal (thromboembolism)
  • Orthopaedic surgery (thromboembolism)
  • Prostate Surgery (thromboembolism)
  • High cardiovascular risk surgeries (> 5%):
  • Aortic surgery with risk of sudden changes in blood pressure during clamping (acute pulmonary edema, ischemia)
  • declamping (coronary perfusion)
  • other major vascular surgery - peripheral vascular surgery - long surgery with significant blood loss or fluid and electrolyte

结局指标

主要结局

occurrence of a complication or cardiovascular events

时间窗: 2 years

The endpoint is the occurrence of a complication or cardiovascular events (composite endpoint). A cardiovascular event is defined by the occurrence of syndromes such as IDM, acute cardiogenic lung edema, a rhythm disturbance (ACFA, flutter, TV, FV) or c

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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