COVID-19 Associated Endothelial Dysfunction Study

Not Applicable

Completed

• Conditions: Microcirculation; Covid19

• Registration Number: NCT04773899
• Lead Sponsor: University Hospital, Angers

Brief 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.

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-02-26
• Study Start: 2021-10-22
• Primary Completion: 2022-10-21
• Study Completion: 2022-12-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endothelial function measured by Near-infrared spectroscopy (NIRS)	within 72 hours of admission in Intensive Care Unit (ICU)	Measure : Saturation Tissue (StO2) after a vascular occlusion test (VOT)

Secondary Outcome Measures

Name	Time	Method
Thrombotic events	Inclusion (V0) up to 8 weeks maximum	measure : All arterial and/or venous thromboembolic events since acute episode
Endothelial function measured by perfusion index	within 72 hours of admission in ICU	measure : Perfusion index after a vascular occlusion test (VOT)
Microvascular reactivity measured laser speckle contrast imaging	within 72 hours of admission in ICU	measure : Vasodilation after iontophoresis of Acetylcholine and Nitroprusside
Morphological analysis by Sublingual videomicroscopy	within 72 hours of admission in ICU	measure : Perfused vessel density (PVD)
Inflammatory status	Inclusion	measure : neutrophil to lymphocyte ratio
Prothrombotic condition	Inclusion	measure : D-Dimer Level and
Severity of lung disease	Inclusion	measure : percentage of pulmonary lesions assessed by CT scan at the ICU admission.
Mortality	Up to 8 weeks after inclusion	measure : Mortality in ICU
Organ failure	Inclusion	measure : Sequential Organ Failure Assessment (SOFA) Score, minimum value 0 and maximum value 24. The higher score means a worse outcome.

Trial Locations

Locations (2)

UH Angers; 🇫🇷 Angers, France

Hopital E.Herriot - Hospices Civils de Lyon; 🇫🇷 Lyon, France