Characterization of the microVAScular Dysfunction in Covid-19 ARDS

• Conditions: ARDS, Human; COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Diagnostic Test: alveolar dead-space quantification; Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations; Diagnostic Test: Endothelial activation / endothelial senescence

• Registration Number: NCT05074758
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-12
• Study Start: 2021-12-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-09-10
• Study Completion: 2022-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-COVID-19 ARDS patients	alveolar dead-space quantification	20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19
non-COVID-19 ARDS patients	Endothelial activation / endothelial senescence	20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19
COVID-19 ARDS patients	Coagulation activation and impaired fibrinolysis explorations	20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19
non-COVID-19 ARDS patients	Coagulation activation and impaired fibrinolysis explorations	20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19
COVID-19 ARDS patients	alveolar dead-space quantification	20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19
COVID-19 ARDS patients	Endothelial activation / endothelial senescence	20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19

Primary Outcome Measures

Name	Time	Method
Prognostic value of alveolar dead space	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 Outcome Measures

Name	Time	Method
Level of circulating endothelial cells	Up to 28 days	To describe the biological parameters of endothelial damage and prognostic value
Prognostic value of the alveolar dead space (measured iteratively)	28 days	To establish the link between alveolar dead-space values and Day 20 mortality and Day-28 invasive ventilator-free days.
Level of endothelial proteomics	Up to 28 days	To describe the biological parameters of endothelial damage and prognostic value
Level of Willebrand Factor	Up to 28 days	To describe the biological parameters of endothelial damage and prognostic value
Level of fragments of plasminogen	Up to 28 days	To describe the biological parameters of endothelial damage and prognostic value
Level of the components of the NETs (Neutrophil Extracellular Traps)	Up to 28 days	To describe the biological parameters of endothelial damage and prognostic value
Level of progenitor cells	Up to 28 days	To describe the biological parameters of endothelial damage and prognostic value
Level of circulating stem cells	Up to 28 days	To describe the biological parameters of endothelial damage and prognostic value
Level of D-dimers	Up to 28 days	To describe the biological parameters of endothelial damage and prognostic value
Level of components of the fibrinolytic system	Up to 28 days	To describe the biological parameters of endothelial damage and prognostic value
Survival rate	90 days

Trial Locations

Locations (1)

Hôpital européen Georges Pompidou; 🇫🇷 Paris, France