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

Systemic Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565277
• Other study ID #: AMRIC Dr.Atoui
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: December 25, 2018

Study information

• Verified date: July 2020
• Source: Health Sciences North Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 25, 2018
• Est. primary completion date: December 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Systemic Inflammatory Response

Intervention

Biological:
• Influenza Vaccine

Drug:
• Placebo

Locations

Country	Name	City	State
Canada	Health Sciences North Research Institute	Sudbury	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Health Sciences North Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pro and anti-inflammatory cytokines and inflammatory markers		Nine Months