Hôpital européen Georges Pompidou
Paris, 75015, France
Completed
NCT Number: NCT05074758
Characterization of the microVAScular Dysfunction in Covid-19 ARDS
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
- 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
Treatment and study plan
alveolar dead-space quantification
Diagnostic Testmeasurement of alveolar dead-space based on volumetric capnography
Coagulation activation and impaired fibrinolysis explorations
Diagnostic Testblood sampling:
- Fibrinolytic components
- NETs components
- Elastase-derived fragments of proteins of interest
Endothelial activation / endothelial senescence
Diagnostic Testcirculating endothelial cells, E-selectin, endoglin, LVEF-A, LVEFR-2, Angiopoietin -1 and -2, cKit and SDF-1 Willebrand factor (activity, antigen, multimeric analysis )
Primary outcomes
-
Prognostic value of alveolar dead space
Time frame: 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 outcomes
-
Prognostic value of the alveolar dead space (measured iteratively)
Time frame: 20 days
To establish the link between alveolar dead-space values and Day 20 mortality
-
Prognostic value of the alveolar dead space (measured iteratively)
Time frame: 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
Time frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
-
Level of progenitor cells
Time frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
-
Level of circulating stem cells
Time frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
-
Level of endothelial proteomics
Time frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
-
Level of D-dimers
Time frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
-
Level of Willebrand Factor
Time frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
-
Level of components of the fibrinolytic system
Time frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
-
Level of fragments of plasminogen
Time frame: 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)
Time frame: Up to 28 days
To describe the biological parameters of endothelial damage and prognostic value
-
Survival rate
Time frame: 90 days
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Collaborators
- National Research Agency, France
Registry information
Acronym: VASCOV
Important dates
- Study start
- 2021
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Oct 12, 2021
- Registry last updated
- Jul 8, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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