COV2ICU-DK: Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19
Study Details
Study Description
Brief Summary
The aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.
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Detailed Description
The mechanisms of the ARDS-like respiratory failure observed in patients with COVID-19 are currently unknown, but may be related to a distinct local immune response within the lung. In the present study, we will examine the cellular and humoral pulmonary immune response in mechanically ventilated patients admitted to the ICU with COVID-19 by examining immune cell profiles, cytokine patterns, and the complement pathway in bronchoalveolar lavage fluid, and relate it to the concomitant systemic inflammatory response. We will examine the patients on day 1-3 and 7-9 after ICU admission.
Study Design
Outcome Measures
Primary Outcome Measures
- White blood cell counts [Day 0 (subsequent to study inclusion in the ICU)]
Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood
- White blood cell counts [Day 7]
Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood
- Lymphocyte populations [Day 0 (subsequent to study inclusion in the ICU)]
Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood
- Lymphocyte populations [Day 7]
Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood
Secondary Outcome Measures
- Cytokines [Day 0 (subsequent to study inclusion in the ICU)]
Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)
- Cytokines [Day 7]
Multiplex assay for measuring cytokines in bronchoalveolar lavage fluid and plasma (e.g. IL-1-beta, IL-1RA, IL-2, IL-6, IL-8, IL-10, IL-17, IL-18, IL-33, IL-35, TGF-beta, TNF-alpha, HMGB1)
- Lectin complement pathway [Day 0 (subsequent to study inclusion in the ICU)]
MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma
- Lectin complement pathway [Day 7]
MBL, ficolin-1, ficolin-2, ficolin-3, and MASPs in bronchoalveolar lavage fluid and plasma
- Microorganisms [Up to 12 weeks]
Growth of pathogenic microorganisms in body fluids (e.g. urine, blood, bronchoalveolar lavage fluid)
- Respiratory pathogens [Day 0 (subsequent to study inclusion in the ICU)]
Respiratory filmarray PCR for testing for pathogens
- Respiratory pathogens [Day 7]
Respiratory filmarray PCR for testing for pathogens
- Ribosomal RNA in the airways [Day 0 (subsequent to study inclusion in the ICU)]
16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid
- Ribosomal RNA in the airways [Day 7]
16S ribosomal RNA (rRNA) and 18S rRNA PCR for bacterial or fungal pathogen identification in bronchoalveolar lavage fluid
- Levels of SARS-CoV-2 in the airways [Day 0 (subsequent to study inclusion in the ICU)]
Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid
- Levels of SARS-CoV-2 in the airways [Day 7]
Semiquant PCR of SARS-CoV-2 in bronchoalveolar lavage fluid
- Surfactant in the airways [Day 0]
Measured in bronchoalveolar lavage fluid by fourier-transform infrared spectroscopy using the dipalmitoylphosphatidylcholine[DPPC]/spingomyelin[SM]) ratio
- Autoantibodies against type I IFNs in the airways [Day 0]
Measured in bronchoalveolarlavage fluid
Other Outcome Measures
- Mortality [Up to 6 months]
ICU mortality
- Mortality II [Up to 6 months]
In hospital mortality
- Blood markers of inflammation [Daily assessment in the ICU up to 12 weeks]
C-reactive protein, procalcitonin, ferritin
- Infiltrates on conventional chest x-ray [Up to 12 weeks]
Number of participants with unilateral infiltrates or bilateral infiltrates and/or air bronchogram
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18y
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Mechanical ventilation
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Verified COVID-19 (throat swab or tracheal aspirate positive for SARS-CoV-2)
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ARDS according to the Berlin definition
Exclusion Criteria:
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Untreated malignant tachycardia or bradycardia
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Suspected or verified intracranial hypertension (ICP > 15 mmHg)
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Unilateral lung ventilation
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Severe non-correctable coagulopathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept. of Intensive Care 542, University Hospital Hvidovre | Hvidovre | Copenhagen | Denmark | 2650 |
Sponsors and Collaborators
- Hvidovre University Hospital
Investigators
- Principal Investigator: Ronni R Plovsing, MD, PhD, Dept. of Intensive Care, University Hospital Hvidovre, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COV2ICU-DK
- H-20023159
- R349-2020-540