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

Sponsor
Health Sciences North Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02565277
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
39.8
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Influenza Vaccine
  • Drug: Placebo
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
The Effect of Influenza Vaccination on the Systemic Inflammatory Response and Myocardial Protection in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Dec 25, 2018
Actual Study Completion Date :
Dec 25, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pro and anti-inflammatory cytokines and inflammatory markers [Nine Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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-BarrĂ© syndrome

    • Immunosuppressive disorders or medications (including oral prednisone >10 mg daily, recent chemotherapy treatment)

    • Emergency cases as determined by the investigator or physician

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Health Sciences North Research Institute Sudbury Ontario Canada P3E5J1

    Sponsors and Collaborators

    • Health Sciences North Research Institute

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rony Atoui, Msc, MD, FRCSC, Cardiac Surgeon, Health Sciences North Research Institute
    ClinicalTrials.gov Identifier:
    NCT02565277
    Other Study ID Numbers:
    • AMRIC Dr.Atoui
    First Posted:
    Oct 1, 2015
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 1, 2020

    Study Results

    No Results Posted as of Jul 29, 2020