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临床试验/NCT02565277
NCT02565277已完成4 期

The Effect of Influenza Vaccination on the Systemic Inflammatory Response and Myocardial Protection in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial

Health Sciences North Research Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Pro and anti-inflammatory cytokines and inflammatory markers

研究概览

简要总结

To assess the impact of influenza vaccination on the overall systemic inflammatory response in patients undergoing cardiac surgery and investigate functional and clinical outcomes in vaccinated patients postoperatively.

详细描述

The investigators propose to perform a single center, double-blind, randomized, placebo-controlled crossover trial analyzing the beneficial effect of the influenza vaccine in patients undergoing cardiac surgery. This study assesses the impact of the influenza vaccination on the overall systemic inflammatory response and investigates the functional and clinical outcome in vaccinated patients after cardiac surgery. The study sample will consist of patients undergoing cardiac surgery at Health Sciences North randomized into 2 groups: 1) those who receive the vaccine or placebo preoperatively, or: 2) those who receive the vaccine or placebo 4-6 weeks postoperatively. Subjects in both groups will be compared using standard laboratory tools to assess the level of various pro- and anti-inflammatory cytokines (IL-6, IL-8,TNF-alpha, IL-10) as well as other cardiac and inflammatory markers (troponins, CRP), at different time intervals intra- and post-operatively. Other clinical outcomes will also be collected prospectively and compared between the 2 groups. These include hemodynamic parameters as well as major postoperative events. Further assessments will include the Frailty Index and Scale (in patients 65+) and length of stay after surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

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

  • Subjects who the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, and able to converse with study personnel)
  • Age 18 years or older
  • Undergoing major cardiac surgery using cardiopulmonary bypass

排除标准

  • Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
  • Participant has received a community available influenza vaccine within <6 months
  • History of Guillain-Barré syndrome
  • Immunosuppressive disorders or medications (including oral prednisone >10 mg daily, recent chemotherapy treatment)
  • Emergency cases as determined by the investigator or physician

研究组 & 干预措施

Influenza Vaccine

Active Comparator

Fluzone injection once IM

干预措施: Influenza Vaccine (Biological)

Placebo

Placebo Comparator

Saline Injection once IM

干预措施: Placebo (Drug)

结局指标

主要结局

Pro and anti-inflammatory cytokines and inflammatory markers

时间窗: Nine Months

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

Rony Atoui

Msc, MD, FRCSC, Cardiac Surgeon

Health Sciences North Research Institute

研究点 (1)

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