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

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ClinicalTrials.gov Identifier: NCT04689477
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 30, 2020
Sponsor:
Collaborators:
Institut de Ciències Fotòniques (ICFO)
Centre de Recerca Matemàtica
Institute of Physics University of Campinas
Information provided by (Responsible Party):
Jaume Mesquida, Corporacion Parc Tauli

Study Description
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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.

Condition or disease Intervention/treatment
COVID-19 Endothelial Function 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 612 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28 days ]
    Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Critical COVID-19 patients with respiratory impairment admitted to the Intensive Care Unit
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04689477


Contacts
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Contact: Jaume Mesquida, MD, PhD +34 937231010 ext 21155 jmesquida@tauli.cat

Locations
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Brazil
Hospital de Clinicas da UNICAMP Recruiting
Campinas, Sao Paulo, Brazil
Contact: Rodrigo Forti       rforti@ifi.unicamp.br   
Sub-Investigator: Rickson Coelho Mesquita         
Mexico
Hospital General de México Recruiting
México, Mexico
Contact: Argelia Pérez Pacheco    27892000 ext 1853    argeliapp@ciencias.unam.mx   
Sub-Investigator: Diana Pineda Vázquez         
Spain
Institut d'Investigació i Innovació Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Jaume Mesquida    +34 937231010 ext 21155    jmesquida@tauli.cat   
Sub-Investigator: Alba Caballer         
Sub-Investigator: Cristina Espinal         
Sub-Investigator: Sara Nogales         
Sub-Investigator: Guillem Gruartmoner         
Hospital Clínic i Provincial de Barcelona Recruiting
Barcelona, Spain
Contact: Pedro Castro, MD       pcastro@clinic.cat   
Hospital Parc Salut Mar Recruiting
Barcelona, Spain
Contact: Judith Marin Corral       jmarin@imim.es   
Sub-Investigator: Clara Vila         
Hospital Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Ricard Ferrer       r.ferrer@vhebron.net   
Sub-Investigator: Marina García de Acilu         
Sponsors and Collaborators
Corporacion Parc Tauli
Institut de Ciències Fotòniques (ICFO)
Centre de Recerca Matemàtica
Institute of Physics University of Campinas
Investigators
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Principal Investigator: Jaume Mesquida, MD, PhD Corporacion Parc Tauli
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jaume Mesquida, MD, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT04689477    
Other Study ID Numbers: 2020/579
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020

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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
Keywords provided by Jaume Mesquida, Corporacion Parc Tauli:
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases