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

Phase 4

Completed

• Conditions: Systemic Inflammatory Response
• Interventions: Biological: Influenza Vaccine; Drug: Placebo

• Registration Number: NCT02565277
• Lead Sponsor: Health Sciences North Research Institute

Brief 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

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2018-12-25
• Study Completion: 2018-12-25
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Influenza Vaccine	Influenza Vaccine	Fluzone injection once IM
Placebo	Placebo	Saline Injection once IM

Primary Outcome Measures

Name	Time	Method
Pro and anti-inflammatory cytokines and inflammatory markers	Nine Months

Trial Locations

Locations (1)

Health Sciences North Research Institute; 🇨🇦 Sudbury, Ontario, Canada