Clinical trial NCT05074758: Characterization of the microVAScular Dysfunction in Covid-19 ARDS
Official title: Characterization of the microVAScular Dysfunction in COvid-19 ARDS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS, Human
COVID-19 Acute Respiratory Distress Syndrome
Keywords: pulmonary biological markers
alveolar dead-space
circulating endothelial cells
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2021-10-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate or severe ARDS linked or not with covid-19

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.

Eligibility 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)
* 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

Primary outcomes:
measure: Prognostic value of alveolar dead space
timeFrame: Up to 28 days
Secondary outcomes:
measure: Prognostic value of the alveolar dead space (measured iteratively)
timeFrame: 20 days
measure: Prognostic value of the alveolar dead space (measured iteratively)
timeFrame: 28 days
measure: Level of circulating endothelial cells
timeFrame: Up to 28 days
measure: Level of progenitor cells
timeFrame: Up to 28 days
measure: Level of circulating stem cells
timeFrame: Up to 28 days
measure: Level of endothelial proteomics
timeFrame: Up to 28 days
measure: Level of D-dimers
timeFrame: Up to 28 days
measure: Level of Willebrand Factor
timeFrame: Up to 28 days
measure: Level of components of the fibrinolytic system
timeFrame: Up to 28 days
measure: Level of fragments of plasminogen
timeFrame: Up to 28 days
measure: Level of the components of the NETs (Neutrophil Extracellular Traps)
timeFrame: Up to 28 days
measure: Survival rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital européen Georges Pompidou
Study officials:
affiliation: AP-HP, Hôpital Européen Georges Pompidou, Paris
name: Jean-Luc Diehl, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.