Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients (HEMOCOVID19)

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Endothelial Function
• Intervention / Treatment: Device: Vascular occlusion test

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.

• Study Type: Observational
• Enrollment (Anticipated): 612

Contacts and Locations

• Study Contact: Name: Jaume Mesquida, MD, PhD; Phone Number: 21155 +34 937231010; Email: jmesquida@tauli.cat

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Recruiting
    • Hospital Das Clínicas University of Sao Paulo Medical School
    • Contact: Leandro U Taniguchi
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil
      • Recruiting
      • Hospital de Clínicas da Unicamp
      • Contact: Rodrigo Forti; Email: rforti@ifi.unicamp.br
      • Sub-Investigator: Rickson Coelho Mesquita
• Mexico
  • México, Mexico
    • Recruiting
    • Hospital General de Mexico
    • Contact: Argelia Pérez Pacheco; Phone Number: 1853 27892000; Email: argeliapp@ciencias.unam.mx
    • Sub-Investigator: Diana Pineda Vázquez
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clínic i Provincial de Barcelona
    • Contact: Pedro Castro, MD; Email: pcastro@clinic.cat
  • Barcelona, Spain
    • Recruiting
    • Hospital Vall D'Hebron
    • Contact: Ricard Ferrer; Email: r.ferrer@vhebron.net
    • Sub-Investigator: Marina García de Acilu
  • Barcelona, Spain
    • Recruiting
    • Hospital Parc Salut Mar
    • Contact: Judith Marin Corral; Email: jmarin@imim.es
    • Sub-Investigator: Clara Vila
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Institut d'Investigació i Innovació Parc Taulí
      • Contact: Jaume Mesquida; Phone Number: 21155 +34 937231010; Email: jmesquida@tauli.cat
      • Sub-Investigator: Alba Caballer
      • Sub-Investigator: Cristina Espinal
      • Sub-Investigator: Sara Nogales
      • Sub-Investigator: Guillem Gruartmoner
• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: David Busch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critical COVID-19 patients with respiratory impairment admitted to the Intensive Care Unit

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Healthy subjects	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.
COVID-19; Hospitalized patients diagnosed with COVID-19, presenting with arterial hypoxemia.	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.
Non-COVID critically ill patients; Non-COVID critically ill patients admitted to the ICU.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19	28 days

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Institut de Ciències Fotòniques (ICFO); Centre de Recerca Matemàtica; Institute of Physics University of Campinas
• Investigators: Principal Investigator: Jaume Mesquida, MD, PhD, Corporacion Parc Tauli

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020/579

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No