VASCOV: Characterization of the microVAScular Dysfunction in Covid-19 ARDS
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| non-COVID-19 ARDS patients 20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19 |
Diagnostic Test: alveolar dead-space quantification
measurement of alveolar dead-space based on volumetric capnography
Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations
blood sampling:
Fibrinolytic components
NETs components
Elastase-derived fragments of proteins of interest
Diagnostic Test: Endothelial activation / endothelial senescence
circulating endothelial cells, E-selectin, endoglin, LVEF-A, LVEFR-2, Angiopoietin -1 and -2, cKit and SDF-1 Willebrand factor (activity, antigen, multimeric analysis )
|
| COVID-19 ARDS patients 20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19 |
Diagnostic Test: alveolar dead-space quantification
measurement of alveolar dead-space based on volumetric capnography
Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations
blood sampling:
Fibrinolytic components
NETs components
Elastase-derived fragments of proteins of interest
Diagnostic Test: Endothelial activation / endothelial senescence
circulating endothelial cells, E-selectin, endoglin, LVEF-A, LVEFR-2, Angiopoietin -1 and -2, cKit and SDF-1 Willebrand factor (activity, antigen, multimeric analysis )
|
Outcome Measures
Primary Outcome Measures
- Prognostic value of alveolar dead space [Up to 28 days]
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.
Secondary Outcome Measures
- Prognostic value of the alveolar dead space (measured iteratively) [20 days]
To establish the link between alveolar dead-space values and Day 20 mortality
- Prognostic value of the alveolar dead space (measured iteratively) [28 days]
To establish the link between alveolar dead-space values and Day 20 mortality and Day-28 invasive ventilator-free days.
- Level of circulating endothelial cells [Up to 28 days]
To describe the biological parameters of endothelial damage and prognostic value
- Level of progenitor cells [Up to 28 days]
To describe the biological parameters of endothelial damage and prognostic value
- Level of circulating stem cells [Up to 28 days]
To describe the biological parameters of endothelial damage and prognostic value
- Level of endothelial proteomics [Up to 28 days]
To describe the biological parameters of endothelial damage and prognostic value
- Level of D-dimers [Up to 28 days]
To describe the biological parameters of endothelial damage and prognostic value
- Level of Willebrand Factor [Up to 28 days]
To describe the biological parameters of endothelial damage and prognostic value
- Level of components of the fibrinolytic system [Up to 28 days]
To describe the biological parameters of endothelial damage and prognostic value
- Level of fragments of plasminogen [Up to 28 days]
To describe the biological parameters of endothelial damage and prognostic value
- Level of the components of the NETs (Neutrophil Extracellular Traps) [Up to 28 days]
To describe the biological parameters of endothelial damage and prognostic value
- Survival rate [90 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age> 18 years old
-
Invasive mechanical ventilation in place for less than 48 hours
-
Severe or moderate ARDS (defined according to the Berlin classification)
-
Virological confirmation by PCR of SARS-CoV-2 infection (ARDS COVID-19)
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Lack of virological confirmation by PCR of SARS-CoV-2 infection (ARDS not linked to COVID-19)
-
Patient information
Exclusion Criteria:
-
Massive pulmonary embolism
-
Chronic respiratory failure under long-term oxygen therapy
-
Dying patient
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital européen Georges Pompidou | Paris | France | 75015 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- National Research Agency, France
Investigators
- Study Chair: Jean-Luc Diehl, PhD, AP-HP, Hôpital Européen Georges Pompidou, Paris
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- APHP210693
- 2021-A01339-32