Covid19 Clinical Trial
— CAUSEDOfficial title:
L'Étude de la Dysfonction endothéliale Dans la Maladie à COVID-19 Chez Des Patients en Soins Critiques.
Verified date | May 2023 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | December 21, 2022 |
Est. primary completion date | October 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria : - Adult patient (= 18 ans) - Affiliation to the French National Healthcare System - Voluntary patient who have given oral consent Cohort C1, COVID19 (+) patients hospitalized in ICU : - Patient admitted to ICU within 72 hours before inclusion - Patient presenting SARS-COV2 pneumonia diagnosed by CT scan or by COVID-19 PCR test. Cohort C2, COVID19 (-) patients hospitalized in ICU : - Patient admitted to ICU within 72 hours before inclusion - All COVID19 PCR tests carried out in the 15 days prior inclusion are negative - All the CT scans possibly performed since the acute event do not show COVID19 pulmonary lesions - Matching with the cases C1 COVID 19 (+) patients on sex, age (threshold at 65 years), treated hypertension, treated diabetes mellitus. 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 major symptoms among : measured fever > 38°C, dry cough, shortness of breath or high respiratory rate (>20/min), anosmia, ageusia - No more than one minor symptom among : sore throat, rhinorrhea, chest pain, myalgia, general alteration or severe tiredness, confusion, disorientation, headache, diarrhea, nausea or/and vomiting, rash/ frostbite/cracking on fingers or hand - No positive COVID19 PCR test within 15 days prior to inclusion Non-inclusion criteria : - Proven sepsis (Procalcitonin >1.0 µg/l) in the 24 hours prior to inclusion - End-stage kidney disease with dialysis - Patient with haemodynamic failure treated by norepinephrine - Patient with traumatic brain injury - Intubated patient and/or sedated - Pregnant woman, parturient and nursing mother - Person restricted in liberty by an administrative or judicial decision - Patient concerned with admission for psychiatric care - Adult person subject to a legal protection measure or unable to express consent Exclusion criteria : • Cohorts C2 and C3 : positive COVID-19 PCR test within 5 days after inclusion |
Country | Name | City | State |
---|---|---|---|
France | UH Angers | Angers | |
France | Hopital E.Herriot - Hospices Civils de Lyon | Lyon |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Secondary | Endothelial function measured by perfusion index | measure : Perfusion index after a vascular occlusion test (VOT) | within 72 hours of admission in ICU | |
Secondary | Microvascular reactivity measured laser speckle contrast imaging | measure : Vasodilation after iontophoresis of Acetylcholine and Nitroprusside | within 72 hours of admission in ICU | |
Secondary | Morphological analysis by Sublingual videomicroscopy | measure : Microvascular flow index (MFI) | within 72 hours of admission in ICU | |
Secondary | Morphological analysis by Sublingual videomicroscopy | measure : Perfused vessel density (PVD) | within 72 hours of admission in ICU | |
Secondary | Inflammatory status | measure : C-reactive protein level | Inclusion | |
Secondary | Inflammatory status | measure : neutrophil to lymphocyte ratio | Inclusion | |
Secondary | Prothrombotic condition | measure : D-Dimer Level and | Inclusion | |
Secondary | Thrombotic events | measure : All arterial and/or venous thromboembolic events since acute episode | Inclusion (V0) up to 8 weeks maximum | |
Secondary | Severity of lung disease | measure : PaO2/FiO2 ratio | Inclusion | |
Secondary | Severity of lung disease | measure : percentage of pulmonary lesions assessed by CT scan at the ICU admission. | Inclusion | |
Secondary | Mortality | measure : Mortality in ICU | Up to 8 weeks after inclusion | |
Secondary | Organ failure | measure : Sequential Organ Failure Assessment (SOFA) Score, minimum value 0 and maximum value 24. The higher score means a worse outcome. | Inclusion |
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