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临床试验/NCT04749212
NCT04749212已完成不适用

Incidence and Clinical Relevance of Perioperative Elevation of Troponin I and N- Terminal Pro-Brain Natriuretic Peptide in Patients Undergoing Lung Resection

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 475 人开始时间: 2021年5月19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
475
试验地点
1
主要终点
NT-proBNP perioperative changes

研究概览

简要总结

After lung resection, troponin elevation may be regulated by mechanisms other than myocardial ischemia. Perioperative natriuretic peptides measurement may help identify changes in ventricular function during thoracic surgery. Integrating both cardiac biomarkers may improve the predictive value for cardiovascular complications after lung resection.

详细描述

Objectives: To evaluate the incidence and magnitude of perioperative N-terminal pro brain natriuretic peptide (NT-proBNP) and high-sensitivity troponin I (Tn I) elevation in patients undergoing pulmonary resection and its predictive value for cardiovascular complications. Methodology: Prospective, multicenter, observational cohort study in patients >45 years undergoing elective thoracic surgery for lung resection. Cardiac biomarkers Tn I and NT-proBNP will be measured preoperatively and at postoperative days 1 and 2. Risk score for major cardiovascular postoperative complications will be calculated depending of both biomarkers perioperative changes.

研究设计

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

入排标准

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

入选标准

  • Age ≥45 years old
  • Patients undergoing elective surgery for lung resection

排除标准

  • Patients undergoing urgent, emergent, or nonthoracic surgery
  • Patients or family did not consent to participate
  • Presence of symptoms related with infection or sepsis
  • Patients with a documented history of severe heart failure and/or ejection fraction lower than 30%

结局指标

主要结局

NT-proBNP perioperative changes

时间窗: Change from baseline NT-proBNP at two-days after surgery

Perioperative change in NT-Pro-Brain Natriuretic Peptide (NT-proBNP) levels in patients undergoing pulmonary resection. Cutt-of values will be NT-proBNP ≥ 300 pg/ml pg/ml

TnI perioperative changes

时间窗: Change from baseline TnI at two-days after surgery

Perioperative changes in high-sensitivity troponin I (TnI) levels in patients undergoing pulmonary resection. Cutt-of values will be TnI ≥45 ng/L

Major cardiovascular complications

时间窗: 30-days after surgery

Postoperative non-fatal cardiac arrest, acute myocardial infarction, angina, congestive heart failure, new clinically relevant cardiac arrhythmia, cardiovascular death

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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