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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Inflammatory Response
• Intervention / Treatment: Drug: Placebo; Biological: Influenza Vaccine

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Sudbury, Ontario, Canada, P3E5J1
      • Health Sciences North Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Influenza Vaccine; Fluzone injection once IM	Biological: Influenza Vaccine; Other Names: Fluzone
Placebo Comparator: Placebo; Saline Injection once IM	Drug: Placebo; Other Names: Saline Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pro and anti-inflammatory cytokines and inflammatory markers	Nine Months

Collaborators and Investigators

• Sponsor: Health Sciences North Research Institute
• Investigators: Principal Investigator: Roni Atoui, MSc MD FRCSC, Health Sciences North Research Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 25, 2018
• Study Completion (Actual): December 25, 2018

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AMRIC Dr.Atoui