COVID-19 Clinical Trial
— HEMOCOVID19Official title:
Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
NCT number | NCT04689477 |
Other study ID # | 2020/579 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 25, 2020 |
Est. completion date | October 2022 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Corporacion Parc Tauli | Centre de Recerca Matemàtica, Institut de Ciències Fotòniques (ICFO), Institute of Physics University of Campinas |
United States, Brazil, Mexico, Spain,
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
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 |
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