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

NCT ID: NCT02565277

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-12-25

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

Conditions

Systemic Inflammatory Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Influenza Vaccine

Fluzone injection once IM

Group Type: ACTIVE_COMPARATOR

Influenza Vaccine

Intervention Type: BIOLOGICAL

Placebo

Saline Injection once IM

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Influenza Vaccine

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: DRUG

Other Intervention Names

Fluzone; Saline Injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Sciences North Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Rony Atoui

Msc, MD, FRCSC, Cardiac Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roni Atoui, MSc MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Health Sciences North Research Institute

Locations

Health Sciences North Research Institute

Greater Sudbury, Ontario, Canada

Countries

Canada

Other Identifiers

AMRIC Dr.Atoui

Identifier Type: -

Identifier Source: org_study_id