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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01271842
First received: January 6, 2011
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long-term Outcome and Lung Capacity in Survivors of ARDS Due to Influenza A (H1N1) v2009 The RESPIFLU Study

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Carbon monoxide diffusion capacity [ Time Frame: At least 9 months after ICU discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: At least 9 months after ICU discharge ] [ Designated as safety issue: No ]
  • Pulmonary function testing [ Time Frame: At least 9 months after ICU discharge ] [ Designated as safety issue: No ]
  • Post traumatic stress disorder [ Time Frame: At least 9 months after ICU discharge ] [ Designated as safety issue: No ]
  • Anxiety and depression [ Time Frame: At least 9 months after ICU discharge ] [ Designated as safety issue: No ]
  • Muscle weakness [ Time Frame: At least 9 months after ICU discharge ] [ Designated as safety issue: No ]
  • Lung abnormalities on CT scan [ Time Frame: At least 9 months after ICU discharge ] [ Designated as safety issue: No ]
  • Alveoli-arterial gradient of oxygen during effort [ Time Frame: At least 9 months after ICU discharge ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: October 2010
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271842

Locations
France
CHU Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Charles-Edouard Luyt, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Institut National de la Santé Et de la Recherche Médicale, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01271842     History of Changes
Other Study ID Numbers: C10-26, 2010-A00741-38
Study First Received: January 6, 2011
Last Updated: December 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Influenza, Human
Stress Disorders, Traumatic
Pulmonary Fibrosis
Stress Disorders, Post-Traumatic
Pneumonia, Viral
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Anxiety Disorders
Mental Disorders
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on October 19, 2014