Clinical trial NCT04689477: Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
Official title: Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Endothelial Function
Keywords: COVID-19
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Institut de Ciències Fotòniques (ICFO)
name: Centre de Recerca Matemàtica
name: Institute of Physics University of Campinas
First posted: 2020-12-30
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critical COVID-19 patients with respiratory impairment admitted to the Intensive Care Unit

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Campinas
country: Brazil
facility: Hospital de Clinicas da UNICAMP
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Das Clínicas University of Sao Paulo Medical School
city: México
country: Mexico
facility: Hospital General de México
city: Sabadell
country: Spain
facility: Institut d'Investigació i Innovació Parc Taulí
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Parc Salut Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Corporacion Parc Tauli
name: Jaume Mesquida, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mesquida J, Caballer A, Cortese L, Vila C, Karadeniz U, Pagliazzi M, Zanoletti M, Pacheco AP, Castro P, Garcia-de-Acilu M, Mesquita RC, Busch DR, Durduran T; HEMOCOVID-19 Consortium. Peripheral microcirculatory alterations are associated with the severity of acute respiratory distress syndrome in COVID-19 patients admitted to intermediate respiratory and intensive care units. Crit Care. 2021 Nov 8;25(1):381. doi: 10.1186/s13054-021-03803-2.