Pre-operative Carriage of Respiratory VIRUSes, and Acute Respiratory Distress Syndrome After Heart Surgery (VIRUS-ATTAC)
Primary Purpose
Heart; Surgery, Heart, Functional Disturbance as Result
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Screening for respiratory virus infection
Sponsored by
About this trial
This is an interventional prevention trial for Heart; Surgery, Heart, Functional Disturbance as Result focused on measuring extracorporal circulation, adrs
Eligibility Criteria
Inclusion Criteria:
- Patients over 18 years of age ;
- Benefiting from cardiac surgery under extracorporeal circulation (ECC);
- Affiliated to a social security scheme;
- And having given free, informed and written consent
Exclusion Criteria:
- Admission for heart transplantation ;
- Admission for implantation of a left heart mechanical assist device or a total artificial heart;
- Patients with fever or flu-like symptoms during preoperative assessment (headache, myalgia, cough, nasal congestion, rhinorrhea)
- Patients participating in another clinical study that may interfere with the procedures in this study
- Persons of full age subject to legal protection (judicial protection, guardianship, trusteeship), persons deprived of their liberty, pregnant or breastfeeding women
Sites / Locations
- APHP Henri Mondor
- CHU Nantes
- APHP La Pitié-Salpétrière
- CHU Poitiers
- CHU Rennes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Addition of a nasopharyngeal swab before surgery
Outcomes
Primary Outcome Measures
Occurrence of ARDS within 7 days after surgery related to influenza virus infection
Occurrence of ARDS in population with a positive test for influenza virus within 7 days after surgery according to Berlin criteria (PMID: 22797452)
Secondary Outcome Measures
Occurrence of ARDS within 7 days after surgery related to respiratory virus infection
Occurrence of ARDS in population with a positive test for one of 16 respiratory virus within 7 days after surgery according to Berlin criteria (PMID: 22797452)
Postoperative respiratory complications
Number or type of postoperative respiratory complications (according to Huzelbos et al PMID: 17047215, and French recommendations SFAR-SRLF 2017)
Morbidity
Number or type of postoperative non respiratory complications and data of hospitalization
Mortality
Number of death
Full Information
NCT ID
NCT04562207
First Posted
September 18, 2020
Last Updated
May 15, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04562207
Brief Title
Pre-operative Carriage of Respiratory VIRUSes, and Acute Respiratory Distress Syndrome After Heart Surgery
Acronym
VIRUS-ATTAC
Official Title
Pre-operative Carriage of Respiratory VIRUSes, and Acute Respiratory Distress Syndrome After Heart Surgery - VIRUS-ATTAC
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart; Surgery, Heart, Functional Disturbance as Result
Keywords
extracorporal circulation, adrs
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Addition of a nasopharyngeal swab before surgery
Intervention Type
Diagnostic Test
Intervention Name(s)
Screening for respiratory virus infection
Intervention Description
Nasopharyngeal swab for screening for respiratory virus infection before surgery
Primary Outcome Measure Information:
Title
Occurrence of ARDS within 7 days after surgery related to influenza virus infection
Description
Occurrence of ARDS in population with a positive test for influenza virus within 7 days after surgery according to Berlin criteria (PMID: 22797452)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Occurrence of ARDS within 7 days after surgery related to respiratory virus infection
Description
Occurrence of ARDS in population with a positive test for one of 16 respiratory virus within 7 days after surgery according to Berlin criteria (PMID: 22797452)
Time Frame
7 days
Title
Postoperative respiratory complications
Description
Number or type of postoperative respiratory complications (according to Huzelbos et al PMID: 17047215, and French recommendations SFAR-SRLF 2017)
Time Frame
28 days
Title
Morbidity
Description
Number or type of postoperative non respiratory complications and data of hospitalization
Time Frame
28 days
Title
Mortality
Description
Number of death
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 18 years of age ;
Benefiting from cardiac surgery under extracorporeal circulation (ECC);
Affiliated to a social security scheme;
And having given free, informed and written consent
Exclusion Criteria:
Admission for heart transplantation ;
Admission for implantation of a left heart mechanical assist device or a total artificial heart;
Patients with fever or flu-like symptoms during preoperative assessment (headache, myalgia, cough, nasal congestion, rhinorrhea)
Patients participating in another clinical study that may interfere with the procedures in this study
Persons of full age subject to legal protection (judicial protection, guardianship, trusteeship), persons deprived of their liberty, pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Nesseler, Md
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHP Henri Mondor
City
Créteil
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
APHP La Pitié-Salpétrière
City
Paris
Country
France
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pre-operative Carriage of Respiratory VIRUSes, and Acute Respiratory Distress Syndrome After Heart Surgery
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