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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04773899
Other study ID # 2021-A00330-41
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2021
Est. completion date December 21, 2022

Study information

Verified date May 2023
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Procedure : Multimodal microvascular assessment at study inclusion
Vascular occlusion test (VOT) performed on the arm. Measurement of the quality of tissue reperfusion by NIRS on the thenar eminence and the digital perfusion index. Microcirculation reactivity is measured for each patient with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of microvascular reactivity: Acetylcholine and Nitroprusside Iontophoresis. Morphological analysis of the microcirculation by sublingual videomicroscopy.

Locations

Country Name City State
France UH Angers Angers
France Hopital E.Herriot - Hospices Civils de Lyon Lyon

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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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