Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients

COVID-19 Clinical Trial

— HEMOCOVID19  

Official title:

Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689477
• Other study ID #: 2020/579
• Status: Recruiting
• Start date: May 25, 2020
• Est. completion date: October 2022

Study information

• Verified date: July 2022
• Source: Corporacion Parc Tauli
• Contact: Jaume Mesquida, MD, PhD
• Phone: +34 937231010
• Email: jmesquida[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients, and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.

Description:

After giving consent to participate in the study, the subjects included in the study will undergo a 15-minute measurement of tissue oxygen saturation (StO2) measured non-invasively on the forearm by means of near-infrared spectroscopy (NIRS). Once a baseline stable StO2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. The test will allow the obtention of a local metabolic rate, and a StO2 recovery rate after the ischemic stimulus. This StO2 recovery rate will be considered as a reflection of the endothelial health of the patient. Patients will be studied as soon as possible after admission to the ICU, and followed-up until ICU discharge or death.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 612
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recent diagnosis of SARS-CoV2 infection
• Arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload.

Exclusion Criteria:

• Severe peripheral vasculopathy
• Raynaud's syndrome
• Skin lesions or trauma in upper limbs interfering the placement of NIRS probe and/or the occlusion tourniquet
• Deep venous thrombosis in the upper limbs

Related Conditions & MeSH terms

• COVID-19
• Endothelial Function

Intervention

Device:
• Vascular occlusion test
The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas da UNICAMP	Campinas	Sao Paulo
Brazil	Hospital Das Clínicas University of Sao Paulo Medical School	Sao Paulo
Mexico	Hospital General de México	México
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Hospital Parc Salut Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Institut d'Investigació i Innovació Parc Taulí	Sabadell	Barcelona
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Centre de Recerca Matemàtica, Institut de Ciències Fotòniques (ICFO), Institute of Physics University of Campinas

Countries where clinical trial is conducted

United States,  Brazil,  Mexico,  Spain, 

References & Publications (1)

Mesquida J, Caballer A, Cortese L, Vila C, Karadeniz U, Pagliazzi M, Zanoletti M, Pacheco AP, Castro P, García-de-Acilu M, Mesquita RC, Busch DR, Durduran T; HEMOCOVID-19 Consortium. Peripheral microcirculatory alterations are associated with the severity — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19	28 days

External Links

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