NCT04773899

COVID-19 Associated Endothelial Dysfunction Study

L'Étude de la Dysfonction endothéliale Dans la Maladie à COVID-19 Chez Des Patients en Soins Critiques.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Covid19
• Microcirculation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-22
• Primary completion: 2022-10-21
• Completion: 2022-12-21
• First posted: 2021-02-26
• Last updated: 2023-05-06

Locations

2 sites across 1 country: France