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Cardiac Performance in Mechanically Ventilated COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04628195
Recruitment Status : Completed
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Clinica Alemana de Santiago
Hospital Barros Luco Trudeau
University of Chile
Information provided by (Responsible Party):
Emilio Valenzuela, Pontificia Universidad Catolica de Chile

Brief Summary:
Although COVID-19 affects primarily the respiratory system, several studies have shown evidence of cardiovascular alterations. Increased troponin levels were observed in a significant proportion of patients and this alteration was associated with higher mortality. In addition, case reports of cardiogenic shock or fulminant myocarditis have been communicated. Likewise, pulmonary embolism (PE), right ventricle dilation, and acute cor pulmonale (ACP) have also been described. Therefore, investigating cardiac function in COVID-19 is highly relevant, particularly in critically ill patients who are usually under sedation and mechanical ventilation, which may further impair cardiovascular function. Thus the objective is to determine the prevalence of left ventricle dysfunction and acute cor pulmonale, and its association with respiratory mechanics, in 100 consecutive critically ill COVID-19 patients, who were assessed with critical care echocardiography (CCE) within the first 24 hours of mechanical ventilation.

Condition or disease
Covid19 Acute Cor Pulmonale Cardiac Failure

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Performance in Mechanically Ventilated Patients With Severe Pneumonia by SARS-CoV-2: Echo-COVID Study
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : August 1, 2020



Primary Outcome Measures :
  1. Percentage of patients with left ventricle dysfunction (hypokinetic) [ Time Frame: 3 month ]
    Hypokinetic left ventricle function (left ventricle ejection fraction <45%)

  2. Percentage of patients with acute cor pulmonale [ Time Frame: 3 month ]
    Acute cor pulmonale was defined as a dilated right ventricle (right ventricle end-diastolic area/left ventricle end-diastolic area ratio >0.6) associated with the presence of paradoxical septum motion


Secondary Outcome Measures :
  1. Differences in respiratory system compliance between patients with and without acute cor pulmonale [ Time Frame: Within the first 24 hours of mechanical ventilation. ]
    Respiratory system compliance is defined as the change in lung volume (Tidal volume, ml) produced by a unit change in pulmonary pressure (driving pressure, cmH2O). The reported value of respiratory system compliance will be reported in ml/cmH2O.

  2. Differences in partial arterial pressure of carbon dioxide (PCO2) between patients with and without acute cor pulmonale [ Time Frame: Within the first 24 hours of mechanical ventilation. ]
    Partial arterial pressure of carbon dioxide will be reported in mmHg.

  3. Differences in PaO2/FiO2 ratio between patients with and without acute cor pulmonale [ Time Frame: Within the first 24 hours of mechanical ventilation. ]
    PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction). The reported value is a positive integer.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe SARS-CoV-2 pneumonia, defined as respiratory failure requiring invasive mechanical ventilation.
Criteria

Inclusion Criteria:

  • Covid-19 confirmed by a positive polymerase chain reaction test
  • Mechanical ventilation

Exclusion Criteria:

  • Up to 24 hours on mechanical ventilation
  • Severe valvulopathy
  • Poor ultrasound window
  • Do-not-resuscitate status

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): NCT04628195


Locations
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Chile
Pontificia Universidad Católica de Chile
Santiago, Región Metropolitana, Chile, 7550028
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Clinica Alemana de Santiago
Hospital Barros Luco Trudeau
University of Chile
Publications:

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Responsible Party: Emilio Valenzuela, M.D. Intensivist, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT04628195    
Other Study ID Numbers: 200422002
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emilio Valenzuela, Pontificia Universidad Catolica de Chile:
Critical Care Echocardiography
Cardiac Function
Acute Cor Pulmonale
COVID-19
Mechanical Ventilation
SARS-CoV-2
Additional relevant MeSH terms:
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Heart Failure
Pulmonary Heart Disease
Heart Diseases
Cardiovascular Diseases