Systemic Inflammatory ResponsePhase 4NCT02565277
The Effect of Influenza Vaccination on the Systemic Inflammatory Response and Myocardial Protection in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
A Phase 4 study testing Influenza Vaccine in people with Systemic Inflammatory Response, run by Health Sciences North Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response
- What is being tested?
- Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to 25 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences North Research Institute
Greater Sudbury, Ontario, P3E5J1
About this study
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.
Read the 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
- Being tested
- Influenza Vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccineBiological
Also called Fluzone
PlaceboDrug
Also called Saline Injection
| Study group | Role | What they receive |
|---|---|---|
| Influenza Vaccine | Active comparator | Fluzone injection once IM Receives: Biological: Influenza Vaccine |
| Placebo | Placebo comparator | Saline Injection once IM Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro and anti-inflammatory cytokines and inflammatory markers
Measured: Nine Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completion25 Dec 2018
- Study completion25 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Sciences North Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roni E Atoui, MSc MD FRCSC, Principal investigator, Health Sciences North Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565277
- Sponsor's protocol ID
- AMRIC Dr.Atoui
- Status last verified
- Jul 2020
- First submitted
- 30 Sep 2015
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Influenza Vaccination on the Systemic Inflammatory Response and Myocardial Protection in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02565277
- Acronym / sponsor ID
- AMRIC Dr.Atoui
- Conditions
- Systemic Inflammatory Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Health Sciences North Research InstituteUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Vaccine | Active comparator | Biological: Influenza VaccineFluzone injection once IM |
| Placebo | Placebo comparator | Drug: PlaceboSaline Injection once IM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza VaccineAlso: Fluzone | Biological | Influenza Vaccine |
| PlaceboAlso: Saline Injection | Drug | Placebo |
Primary outcome
Pro and anti-inflammatory cytokines and inflammatory markers
Time frame: Nine Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roni E Atoui, MSc MD FRCSC principal investigator
Health Sciences North Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza Vaccine in people with Systemic Inflammatory Response, run by Health Sciences North Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pro and anti-inflammatory cytokines and inflammatory markers (time frame: Nine Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.