NCT04689477

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
612

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
4 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

December 29, 2020

Last Update Submit

July 27, 2022

Conditions

COVID-19Endothelial Function

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19

    28 days

Study Arms (3)

COVID-19

Hospitalized patients diagnosed with COVID-19, presenting with arterial hypoxemia.

Device: Vascular occlusion test

Control

Healthy subjects

Device: Vascular occlusion test

Non-COVID critically ill patients

Non-COVID critically ill patients admitted to the ICU.

Device: Vascular occlusion test

Interventions

Vascular occlusion testDEVICE

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-19ControlNon-COVID critically ill patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Recent diagnosis of SARS-CoV2 infection
  • Arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Hospital de Clinicas da UNICAMP

Campinas, São Paulo, Brazil

RECRUITING

Hospital Das Clínicas University of Sao Paulo Medical School

São Paulo, Brazil

RECRUITING

Hospital General de México

México, Mexico

RECRUITING

Institut d'Investigació i Innovació Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain

RECRUITING

Hospital Parc Salut Mar

Barcelona, Spain

RECRUITING

Hospital Vall d'Hebron

Barcelona, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34749792RESULT

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jaume Mesquida, MD, PhD

    Corporacion Parc Tauli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaume Mesquida, MD, PhD

CONTACT

+34 937231010jmesquida@tauli.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 29, 2020

First Posted

December 30, 2020

Study Start

May 25, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations

US(1)ME(1)BR(2)ES(4)