MIcrovascular Dysfunction in CRitically Ill cOVID-19 Patients

NCT04819802 | Unknown

• 2 other identifiers: APHP2102492021-A00321-40
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Microcirculatory dysfunction appears to play a key role in the development of organ failure leading to the death of patients with coronavirus disease 2019 (Covid-19). It is still uncertain today whether this damage is secondary to direct viral infection of endothelial cells or the consequence of the inappropriate inflammatory response induced by the infection. The analysis of endothelial and microcirculatory dysfunctions and glycocalyx degradation therefore appears to be necessary in the understanding of the pathophysiological mechanisms of Covid sepsis and could play a role in the evaluation of the efficacy of certain therapeutics which would aim at improving regional perfusion by decreasing microcirculatory dysfunction.However, the analysis of microcirculatory failure, endothelial dysfunction and glycocalyx degradation has so far only been evaluated in small cohorts, without quantitative analysis of microcirculatory perfusion

Conditions

Covid-19; Critical Illness; Hemodynamics; SARS-CoV Infection

Keywords

Covid-19; Covid-19 / Pathophysiology; Covid-19 / Virology; Critical illness; Hemodynamics; Intensive Care Units; Microcirculation; Microcirculation / Physiology; Microvessels / Physiopathology; Capillary permeability; Prospective Studies; SARS-CoV-2; SARS-CoV-2 / physiology; Biomarkers / Blood; Glycocalyx / metabolism; Glycocalyx / Pathology; Regional blood flow; Mouth mucosa / Blood supply; Syndecan-1 / Blood; Organ dysfunction scores

Outcome Measures

Primary Outcomes (1)

• Change in Microvascular flow index (MFI)

  Change in a semi quantitative score evaluating the sublingual microcirculation using an incident dark field imaging device (Microscan, MicroVision Medical ) over the first days of ICU stay

  At admission, on day 1 and day 2

Secondary Outcomes (16)

• Change in perfused vessel density

  At admission, on day 1 and day 2

• Change in plasma Syndecan-1 levels (in pg/ml)

  At admission, on day 1 and day 2

• Change in plasma Thrombomodulin levels (in arbitrary units/ml)

  At admission, on day 1 and day 2

• Change in plasma VEGF-A levels (in arbitrary units/ml)

  At admission, on day 1 and day 2

• Change in plasma Angiopoietin-2 levels (in ng/ml)

  At admission, on day 1 and day 2

Study Arms (1)

Covid-19 patients

Adult Covid-19 patients admitted to intensive care units

Other: Measurement of sublingual microcirculation; Other: Plasma sampling

Interventions

Measurement of sublingual microcirculation OTHER

Sublingual microcirculation will be evaluated using a MicroScan (Microvision Medical, Amsterdam, the Netherlands) incident dark field imaging device. Perfusion measurements will be taken once a day during the first three days after inclusion (i.e. three measurement times). At each measurement time, five sequences of 20 secs will be recorded at five different sites. The video clips will be secondarily analyzed by a trained, blind investigator.

Covid-19 patients

Plasma sampling OTHER

Additional volume during blood draw to assess plasma levels of the following endothelial markers: syndecan-1, angiopoietin-2, vascular endothelial growth factor-A (VEGF-A), thrombomodulin.

Covid-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to ICU for COVID-19

You may qualify if:

• Adult patient (≥ 18 ans)
• Affiliation to the French social security system
• Patient presenting SARS-CoV-2 pneumonia diagnosed by CT scan or by COVID-19 PCR test

You may not qualify if:

• Lesions of the oral mucosa

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Surgical Intensive Care Unit - Kremlin Bicêtre Hospital, APHP

Le Kremlin-Bicêtre, 94270, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Critical Illness; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacques Duranteau, MD, PhD

  APHP, Kremlin Bicêtre Hospital

  STUDY DIRECTOR

Central Study Contacts

Benjamin Bergis, MD

CONTACT

+33145212367; benjamin.bergis@aphp.fr

Anatole Harrois, MD, PhD

CONTACT

Anatole.harrois@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: March 28, 2021
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

FR (1)