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SARS-CoV-2 enters human cells through the binding of the spike protein with angiotensin converting enzyme-2 (ACE2), a membrane receptor highly expressed in immune or non-immune cells, and in many organs, including lungs and endothelial cells.
In COVID-19 disease, the infection of endothelial might cause an acute endothelial dysfunction.
The objective of this study is to demonstrate that patients COVID19 (+) hospitalized in ICU present an acute endothelial dysfunction (compared with COVID19 (-) also hospitalized in ICU).
This acute endothelial dysfunction could lead to organ failure, systemic immune dysregulation and thrombosis.
This cohort study compares 3 exposure cohorts :
Cohort C1 includes COVID19 (+) patients admitted in ICU in whom the diagnosis of COVID19 pneumonia was confirmed.
Cohort C2 includes COVID 19 (-) matched patients also admitted in ICU.
Cohort C3 is a control group. Patients with few comorbidities, ASA 1, recruited during preoperative assessment for elective surgery.
Eligible patients are included within 72 hours of ICU admission (C1, C2) or during the preoperative assessment (C3). Oral consent is needed after complete explanation of the protocol.
During inclusion visit (V0), patient characteristics as treatments, medical history, clinical and biological data are registered.
Microcirculation is assessed for each patient directly after inclusion.
For patients in C1 and C2 a follow-up is planned. This visit (V1) occurs when the patient is discharged from ICU or the day of his death if it occurs in ICU. In case of prolonged stay in ICU, V1 is carried out 2 months after inclusion. During V1, arterial and/or venous thromboembolic events and mortality in ICU is registered.
For Patients in C3, no follow-up is planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort C1 | Other | COVID19 (+) ICU patients with COVID19 pneumonia. |
|
| Cohort C2 | Other | COVID19 (-) matched ICU patients |
|
| Cohort C3 | Other | COVID19 (-) ASA 1 non-hospitalized patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure : Multimodal microvascular assessment at study inclusion | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function measured by Near-infrared spectroscopy (NIRS) | Measure : Saturation Tissue (StO2) after a vascular occlusion test (VOT) | within 72 hours of admission in Intensive Care Unit (ICU) |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function measured by perfusion index | measure : Perfusion index after a vascular occlusion test (VOT) | within 72 hours of admission in ICU |
| Microvascular reactivity measured laser speckle contrast imaging |
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Inclusion criteria :
Cohort C1, COVID19 (+) patients hospitalized in ICU :
Cohort C2, COVID19 (-) patients hospitalized in ICU :
Cohort C3, elective surgery patients who are not hospitalized in ICU :
ASA 1 classification (no major comorbidity, a normaly healthy patient)
Asymptomatic to COVID19 according to French Anesthesiology Society 2020 :
No positive COVID19 PCR test within 15 days prior to inclusion
Non-inclusion criteria :
Exclusion criteria :
• Cohorts C2 and C3 : positive COVID-19 PCR test within 5 days after inclusion
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| Name | Affiliation | Role |
|---|---|---|
| Samir HENNI, MD PhD | UH Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Angers | Angers | 49933 | France | |||
| Hopital E.Herriot - Hospices Civils de Lyon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39158987 | Derived | Abrard S, Coquet T, Riou J, Rineau E, Hersant J, Vincent A, Cordoval J, Jacquet-Lagreze M, Allaouchiche B, Lukaszewicz AC, Henni S. DETECTION AND QUANTIFICATION OF MICROCIRCULATORY DYSFUNCTION IN SEVERE COVID-19 NOT REQUIRING MECHANICAL VENTILATION: A THREE-ARM COHORT STUDY. Shock. 2024 Nov 1;62(5):673-681. doi: 10.1097/SHK.0000000000002451. Epub 2024 Aug 12. English, French. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
measure : Vasodilation after iontophoresis of Acetylcholine and Nitroprusside
| within 72 hours of admission in ICU |
| Morphological analysis by Sublingual videomicroscopy | measure : Microvascular flow index (MFI) | within 72 hours of admission in ICU |
| Morphological analysis by Sublingual videomicroscopy | measure : Perfused vessel density (PVD) | within 72 hours of admission in ICU |
| Inflammatory status | measure : C-reactive protein level | Inclusion |
| Inflammatory status | measure : neutrophil to lymphocyte ratio | Inclusion |
| Prothrombotic condition | measure : D-Dimer Level and | Inclusion |
| Thrombotic events | measure : All arterial and/or venous thromboembolic events since acute episode | Inclusion (V0) up to 8 weeks maximum |
| Severity of lung disease | measure : PaO2/FiO2 ratio | Inclusion |
| Severity of lung disease | measure : percentage of pulmonary lesions assessed by CT scan at the ICU admission. | Inclusion |
| Mortality | measure : Mortality in ICU | Up to 8 weeks after inclusion |
| Organ failure | measure : Sequential Organ Failure Assessment (SOFA) Score, minimum value 0 and maximum value 24. The higher score means a worse outcome. | Inclusion |
| Lyon |
| 69437 |
| France |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |