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Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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