Characterization of the microVAScular Dysfunction in Covid-19 ARDS
NCT ID: NCT05074758
Last Updated: 2022-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2021-12-10
2022-09-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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non-COVID-19 ARDS patients
20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19
alveolar dead-space quantification
measurement of alveolar dead-space based on volumetric capnography
Coagulation activation and impaired fibrinolysis explorations
blood sampling:
* Fibrinolytic components
* NETs components
* Elastase-derived fragments of proteins of interest
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
alveolar dead-space quantification
measurement of alveolar dead-space based on volumetric capnography
Coagulation activation and impaired fibrinolysis explorations
blood sampling:
* Fibrinolytic components
* NETs components
* Elastase-derived fragments of proteins of interest
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 )
Interventions
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alveolar dead-space quantification
measurement of alveolar dead-space based on volumetric capnography
Coagulation activation and impaired fibrinolysis explorations
blood sampling:
* Fibrinolytic components
* NETs components
* Elastase-derived fragments of proteins of interest
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 )
Eligibility Criteria
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Inclusion Criteria
* 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
* Chronic respiratory failure under long-term oxygen therapy
* Dying patient
18 Years
ALL
No
Sponsors
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National Research Agency, France
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Luc Diehl, PhD
Role: STUDY_CHAIR
AP-HP, Hôpital Européen Georges Pompidou, Paris
Locations
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Hôpital européen Georges Pompidou
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Diehl Jean-Luc, PhD
Role: primary
References
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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.
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.
Other Identifiers
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2021-A01339-32
Identifier Type: OTHER
Identifier Source: secondary_id
APHP210693
Identifier Type: -
Identifier Source: org_study_id
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