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Clinical Trials/NCT05074758
NCT05074758
Unknown
Not Applicable

Characterization of the microVAScular Dysfunction in COvid-19 ARDS

Assistance Publique - Hôpitaux de Paris1 site in 1 country40 target enrollmentDecember 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS, Human
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
40
Locations
1
Primary Endpoint
Prognostic value of alveolar dead space
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2021
End Date
September 10, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

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

  • Level of circulating endothelial cells(Up to 28 days)
  • Prognostic value of the alveolar dead space (measured iteratively)(28 days)
  • Level of endothelial proteomics(Up to 28 days)
  • Level of Willebrand Factor(Up to 28 days)
  • Level of fragments of plasminogen(Up to 28 days)
  • Level of the components of the NETs (Neutrophil Extracellular Traps)(Up to 28 days)
  • Level of progenitor cells(Up to 28 days)
  • Level of circulating stem cells(Up to 28 days)
  • Level of D-dimers(Up to 28 days)
  • Level of components of the fibrinolytic system(Up to 28 days)
  • Survival rate(90 days)

Study Sites (1)

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