Characterization of the microVAScular Dysfunction in Covid-19 ARDS

NCT ID: NCT05074758

Last Updated: 2022-01-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-10

Study Completion Date

2022-09-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ARDS, Human COVID-19 Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

measurement of alveolar dead-space based on volumetric capnography

Coagulation activation and impaired fibrinolysis explorations

Intervention Type DIAGNOSTIC_TEST

blood sampling:

* Fibrinolytic components
* NETs components
* Elastase-derived fragments of proteins of interest

Endothelial activation / endothelial senescence

Intervention Type 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 )

COVID-19 ARDS patients

20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19

alveolar dead-space quantification

Intervention Type DIAGNOSTIC_TEST

measurement of alveolar dead-space based on volumetric capnography

Coagulation activation and impaired fibrinolysis explorations

Intervention Type DIAGNOSTIC_TEST

blood sampling:

* Fibrinolytic components
* NETs components
* Elastase-derived fragments of proteins of interest

Endothelial activation / endothelial senescence

Intervention Type 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 )

Interventions

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alveolar dead-space quantification

measurement of alveolar dead-space based on volumetric capnography

Intervention Type DIAGNOSTIC_TEST

Coagulation activation and impaired fibrinolysis explorations

blood sampling:

* Fibrinolytic components
* NETs components
* Elastase-derived fragments of proteins of interest

Intervention Type 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 )

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Agency, France

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Josephine Braun, PhD

Role: CONTACT

01 44 84 17 38

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.

Reference Type BACKGROUND
PMID: 32676824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32437596 (View on PubMed)

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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