Pre-operative Carriage of Respiratory VIRUSes, and Acute Respiratory Distress Syndrome After Heart Surgery

NCT04562207 | Completed

• 1 other identifier: 35RC19_8869_VIRUS-ATTAC
• Study Type: interventional
• Target: 1,256
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Keywords

extracorporal circulation; adrs

Outcome Measures

Primary Outcomes (1)

• 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)

  7 days

Secondary Outcomes (4)

• Occurrence of ARDS within 7 days after surgery related to respiratory virus infection

  7 days

• Postoperative respiratory complications

  28 days

• Morbidity

  28 days

• Mortality

  28 days

Study Arms (1)

Patients

EXPERIMENTAL

Addition of a nasopharyngeal swab before surgery

Diagnostic Test: Screening for respiratory virus infection

Interventions

Screening for respiratory virus infection DIAGNOSTIC_TEST

Nasopharyngeal swab for screening for respiratory virus infection before surgery

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (5)

APHP Henri Mondor

Créteil, France

Location

CHU Nantes

Nantes, France

Location

APHP La Pitié-Salpétrière

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rennes

Rennes, 35000, France

Location

MeSH Terms

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Nicolas Nesseler, Md

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: February 9, 2021
• Primary Completion: February 10, 2023
• Study Completion: March 10, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)