NCT02565277

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Health Sciences North Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Systemic Inflammatory Response

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine
DRUG	Placebo

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-12-25
• Completion: 2018-12-25
• First posted: 2015-10-01
• Last updated: 2020-07-29

Locations

1 site across 1 country: Canada