Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04562207 |
| Other study ID # |
35RC19_8869_VIRUS-ATTAC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 9, 2021 |
| Est. completion date |
March 10, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Rennes University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The main objective of our study is to determine whether asymptomatic influenza virus carriage
is associated with an increased risk of post-operative Acute Respiratory Distress Syndrome
(ARDS) after cardiac surgery. Cardiac surgery patients are particularly at risk of developing
ARDS with an estimated incidence of 5-10% based on the most recent data.
Description:
The primary objective of our study is to determine whether asymptomatic influenza virus
carriage is associated with an increased risk of post-operative Acute Respiratory Distress
Syndrome (ARDS) after cardiac surgery. Cardiac surgery patients are particularly at risk of
developing ARDS, with an estimated incidence of 5-10% based on the most recent data. Acute
Respiratory Distress Syndrome (ARDS) is an acute pulmonary attack of inflammatory origin.
ARDS is the main cause of hypoxemic postoperative respiratory distress. Hospital mortality
associated with ARDS is estimated at 35-46% depending on the degree of severity, and
survivors are at increased risk of cognitive decline, depression, post-traumatic stress, or
musculoskeletal weakness.
Recently, asymptomatic carriage of respiratory viruses, including the influenza virus, has
been identified as a potential risk factor for respiratory complications, including ARDS,
after cardiac surgery. In a monocentric observational cohort, Groeneveld et al. recently
reported that performing scheduled cardiac surgery during the influenza season was associated
with a significantly longer duration of postoperative mechanical ventilation and a higher
incidence of postoperative ARDS compared to surgery performed outside the influenza season
(OR 1.85 95%CI 1.06-3.23 p=0.03). While it is estimated that up to 77% of patients with
positive influenza tests are asymptomatic in the general population, the authors hypothesized
that asymptomatic viral lung carriage would act as pulmonary priming, which, in combination
with other types of pulmonary attacks encountered during surgery, would predispose to the
genesis of ARDS. However, Groeneveld et al. had not tested any respiratory viruses in their
cohort. In addition, the relatively higher influenza vaccination rate in the Netherlands in
this at-risk population (77%) suggests that other types of respiratory viruses may have
contributed to the observed effect.
These data are of major interest. Indeed, in France, during the 2017-2018 epidemic season,
the vaccination rate of individuals at risk was only 46%, with an estimated vaccine efficacy
of only 54% in elderly patients.
The aim of this study is to determine if there is an association between asymptomatic
carriage of respiratory virus, especially influenza virus, and the occurrence of
post-operative complications, morbidity and mortality.
If an association between asymptomatic carriage of influenza virus, or other respiratory
viruses, and the occurrence of post-operative respiratory complications, including ARDS, is
confirmed, a policy of routine immunization prior to cardiac surgery or postponement of
scheduled surgery in the event of a positive viral test could be a simple and inexpensive
strategy to reduce these complications after cardiac surgery. Pre-emptive antiviral therapy
could be discussed when neither of these strategies is possible (e.g., emergency surgery).
