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Characterization of the microVAScular Dysfunction in Covid-19 ARDS

Characterization of the microVAScular Dysfunction in COvid-19 ARDS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05074758
Acronym
VASCOV
Enrollment
39
Registered
2021-10-12
Start date
2021-12-10
Completion date
2023-03-06
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human, COVID-19 Acute Respiratory Distress Syndrome

Keywords

pulmonary biological markers, alveolar dead-space, circulating endothelial cells

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.

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.

Interventions

DIAGNOSTIC_TESTalveolar dead-space quantification

measurement of alveolar dead-space based on volumetric capnography

DIAGNOSTIC_TESTCoagulation activation and impaired fibrinolysis explorations

blood sampling: * Fibrinolytic components * NETs components * Elastase-derived fragments of proteins of interest

DIAGNOSTIC_TESTEndothelial 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 )

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
National Research Agency, France
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prognostic value of alveolar dead spaceUp to 28 daysRecording 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

MeasureTime frameDescription
Prognostic value of the alveolar dead space (measured iteratively)20 daysTo establish the link between alveolar dead-space values and Day 20 mortality
Level of circulating endothelial cellsUp to 28 daysTo describe the biological parameters of endothelial damage and prognostic value
Level of progenitor cellsUp to 28 daysTo describe the biological parameters of endothelial damage and prognostic value
Level of circulating stem cellsUp to 28 daysTo describe the biological parameters of endothelial damage and prognostic value
Level of endothelial proteomicsUp to 28 daysTo describe the biological parameters of endothelial damage and prognostic value
Level of D-dimersUp to 28 daysTo describe the biological parameters of endothelial damage and prognostic value
Level of Willebrand FactorUp to 28 daysTo describe the biological parameters of endothelial damage and prognostic value
Level of components of the fibrinolytic systemUp to 28 daysTo describe the biological parameters of endothelial damage and prognostic value
Level of fragments of plasminogenUp to 28 daysTo describe the biological parameters of endothelial damage and prognostic value
Level of the components of the NETs (Neutrophil Extracellular Traps)Up to 28 daysTo describe the biological parameters of endothelial damage and prognostic value
Survival rate90 days

Countries

France

Contacts

STUDY_CHAIRJean-Luc Diehl, PhD

AP-HP, Hôpital Européen Georges Pompidou, Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026