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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01339-32 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé |
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| Name | Class |
|---|---|
| National Research Agency, France | OTHER |
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The primary endpoint of this research is to establish that the alveolar dead space is significantly higher in patients with COVID-19 ARDS, compared to patients with non-COVID-19 ARDS.
Secondarily, the investigators want to establish the prognostic value of the alveolar-dead space (measured iteratively) in patients with COVID-19 and non-COVID-19 ARDS, to establish the respective influences of the biological parameters of endothelial damage, of the biological parameters of coagulopathy, of the parameters set on the artificial ventilator on the value of the alveolar dead space; in ARDS patients with COVID-19 and non-COVID-19 ARDS, to establish the prognostic value of the laboratory parameters of endothelial damage and coagulopathy in patients with COVID-19 and non-COVID-19 ARDS.
Endothelial damage and coagulation activation at the lung microvascular level may play an important role in the physiopathology of the COVID-19 ARDS. The project aims to prospectively investigate both bedside pulmonary physiological markers and biological markers of coagulopathy and endothelial dysfunction in COVID-19 and non-COVID-19 ARDS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-COVID-19 ARDS patients | 20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19 |
| |
| COVID-19 ARDS patients | 20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alveolar dead-space quantification | Diagnostic Test | measurement of alveolar dead-space based on volumetric capnography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic value of alveolar dead space | Recording the exhaled CO2 curve (side-stream capnography method) and volume curve, as determined by the mechanical ventilator, and computing the signals with the arterial CO2 partial pressure, reflecting the partial pressure of CO2 in the alveoli participating in gas exchanges), determined on arterial blood gas (ABG) sampling. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic value of the alveolar dead space (measured iteratively) | To establish the link between alveolar dead-space values and Day 20 mortality | 20 days |
| Prognostic value of the alveolar dead space (measured iteratively) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate or severe ARDS linked or not with covid-19
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc Diehl, PhD | AP-HP, Hôpital Européen Georges Pompidou, Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital européen Georges Pompidou | Paris | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32676824 | Background | Diehl JL, Peron N, Chocron R, Debuc B, Guerot E, Hauw-Berlemont C, Hermann B, Augy JL, Younan R, Novara A, Langlais J, Khider L, Gendron N, Goudot G, Fagon JF, Mirault T, Smadja DM. Respiratory mechanics and gas exchanges in the early course of COVID-19 ARDS: a hypothesis-generating study. Ann Intensive Care. 2020 Jul 16;10(1):95. doi: 10.1186/s13613-020-00716-1. | |
| 32437596 |
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Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
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blood samples citrated tubes blood samples EDTA tubes
| Coagulation activation and impaired fibrinolysis explorations | Diagnostic Test | blood sampling:
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| Endothelial activation / endothelial senescence | Diagnostic Test | circulating endothelial cells, E-selectin, endoglin, LVEF-A, LVEFR-2, Angiopoietin -1 and -2, cKit and SDF-1 Willebrand factor (activity, antigen, multimeric analysis ) |
|
To establish the link between alveolar dead-space values and Day 20 mortality and Day-28 invasive ventilator-free days.
| 28 days |
| Level of circulating endothelial cells | To describe the biological parameters of endothelial damage and prognostic value | Up to 28 days |
| Level of progenitor cells | To describe the biological parameters of endothelial damage and prognostic value | Up to 28 days |
| Level of circulating stem cells | To describe the biological parameters of endothelial damage and prognostic value | Up to 28 days |
| Level of endothelial proteomics | To describe the biological parameters of endothelial damage and prognostic value | Up to 28 days |
| Level of D-dimers | To describe the biological parameters of endothelial damage and prognostic value | Up to 28 days |
| Level of Willebrand Factor | To describe the biological parameters of endothelial damage and prognostic value | Up to 28 days |
| Level of components of the fibrinolytic system | To describe the biological parameters of endothelial damage and prognostic value | Up to 28 days |
| Level of fragments of plasminogen | To describe the biological parameters of endothelial damage and prognostic value | Up to 28 days |
| Level of the components of the NETs (Neutrophil Extracellular Traps) | To describe the biological parameters of endothelial damage and prognostic value | Up to 28 days |
| Survival rate | 90 days |
| Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21. |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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