Long-term Outcome and Lung Capacity in Survivors of ARDS Due to Influenza A (H1N1) v2009 The RESPIFLU Study

NCT01271842 | Completed

• 2 other identifiers: C10-262010-A00741-38
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza A (H1N1) v2009 infection was responsible throughout the world of viral pneumonia and severe pulmonary edema requiring rescue therapeutics such as extracorporeal oxygenation. To date, no data exist on the outcome of patients having developed acute respiratory distress syndrome (ARDS) due to influenza A (H1N1) v2009, and in particular in patients with very severe lung injury requiring extracorporeal oxygenation. Although data exist on long-term outcome of survivors of ARDS, the patients included in the observational studies were heterogeneous with various underlying disease. Moreover, no study compared the outcome of survivors of ARDS according to the need or not of extracorporeal oxygenation. We therefore conducted this prospective case-control study to compare the long term pulmonary and extra pulmonary function in 2 groups of patients, one with severe ARDS due to H1N1 requiring extracorporeal oxygenation (case), and the second with ARDS due to H1N1 but without need for extracorporeal oxygenation (control). Eighteen case patients with inclusion and without non-inclusion criteria were selected from our national registry, and 32 controls (with inclusion and exclusion criteria) were matched on age, sex, and body mass index. All 48 patients will be contacted and asked to participate. Patients will be evaluate at least 9 months after ICU discharge, looking for health-related quality of life, measured by the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), post traumatic stress disorder, assessed by the Impact of Event Scale Anxiety, and depression, assessed by the Hospital and Depression Score. Pulmonary function testing, including VO2 max test on a static bike will be performed. Muscle weakness will be clinically evaluated by the medical council research (MRC) test, with an additional electromyography if the result of the test was \<48/60. A CT-scan will be performed, looking for lung abnormalities (fibrosis...). Albumin and prealbumin will be measured to evaluate the nutritional status. Primary outcome measurement is carbon monoxide diffusion capacity. The primary hypothesis is that patients with extracorporeal oxygenation will have a carbon monoxide diffusion capacity lower than patients without extracorporeal oxygenation (15% difference between groups). Inclusion of 13 patients in the case group and 26 patients in the control group will allow testing this hypothesis with a statistical power of 80% (standard deviation 15%). Secondary outcome measures will be the quality of life, the presence or not of post-traumatic stress disorders, of anxiety and/or depression, the results of pulmonary function testing, of the CT-scan, and of muscle testing. All results will be compared in patients with and without extracorporeal oxygenation.

Conditions

Influenza; Pneumonia, Viral; Pulmonary Fibrosis; Quality of Life; Stress Disorders, Post Traumatic

Outcome Measures

Primary Outcomes (1)

• Carbon monoxide diffusion capacity

  At least 9 months after ICU discharge

Secondary Outcomes (7)

• Health-related quality of life

  At least 9 months after ICU discharge

• Pulmonary function testing

  At least 9 months after ICU discharge

• Post traumatic stress disorder

  At least 9 months after ICU discharge

• Anxiety and depression

  At least 9 months after ICU discharge

• Muscle weakness

  At least 9 months after ICU discharge

Study Arms (2)

Extra corporeal oxygenation

Survivors of ARDS due to influenza A (H1N1)2009 infection who needed an extracorporeal oxygenation at the time of infection

No extracorporeal oxygenation

Survivors of ARDS due to influenza A (H1N1) 2009 infection who did not need an extracorporeal oxygenation at the time of infection

Eligibility Criteria

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

Study Population

Two groups of survivors of severe acute respiratory distress syndrome due to influenza A H1N1 infection will be recruited; the first required extracorporeal oxygenation at the time of viral infection, and the second did not require extracorporeal oxygenation at the time of viral infection. Patients will be recruited at least 9 months after ICU discharge. Eighteen case patients matching inclusion and non-inclusion criteria were selected from our national registry, and 32 controls (with inclusion and exclusion criteria) were matched on age, sex, and body mass index.

You may qualify if:

• Patients from 18 to 65 year-old
• Survivors of ARDS due to influenza A (H1N1) v2009 infection developed during the winter 2009-2010
• Influenza A (H1N1) infection confirmed by RT-PCR
• Written consent
• Need or not for extra corporeal lung oxygenation

You may not qualify if:

• Pre existing pulmonary disease
• Asthma
• Diabetes mellitus
• Immunodepression
• Cancer
• Severe obesity (BMI \>35 kg/m²)
• Neuromuscular disease
• Pre existing cardiac disease
• Chronic renal failure
• Liver failure
• Stroke
• Pregnancy

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

CHU Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

• Luyt CE, Combes A, Becquemin MH, Beigelman-Aubry C, Hatem S, Brun AL, Zraik N, Carrat F, Grenier PA, Richard JM, Mercat A, Brochard L, Brun-Buisson C, Chastre J; REVA Study Group. Long-term outcomes of pandemic 2009 influenza A(H1N1)-associated severe ARDS. Chest. 2012 Sep;142(3):583-592. doi: 10.1378/chest.11-2196.

  PMID: 22948576 RESULT

MeSH Terms

Conditions

Influenza, Human; Pneumonia, Viral; Pulmonary Fibrosis; Combat Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Charles-Edouard Luyt, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 7, 2011
• Study Start: October 1, 2010
• Primary Completion: October 2, 2011
• Study Completion: October 2, 2011
• Last Updated: October 7, 2025

Record last verified: 2012-12

Locations

FR (1)