Covid19 Clinical Trial
Official title:
Cardiac Performance in Mechanically Ventilated Patients With Severe Pneumonia by SARS-CoV-2: Echo-COVID Study
NCT number | NCT04628195 |
Other study ID # | 200422002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2020 |
Est. completion date | August 1, 2020 |
Verified date | November 2020 |
Source | Pontificia Universidad Catolica de Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 1, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Chile | Pontificia Universidad Católica de Chile | Santiago | Región Metropolitana |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile | Clinica Alemana de Santiago, Hospital Barros Luco Trudeau, University of Chile |
Chile,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with left ventricle dysfunction (hypokinetic) | Hypokinetic left ventricle function (left ventricle ejection fraction <45%) | 3 month | |
Primary | Percentage of patients with acute cor pulmonale | 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 | 3 month | |
Secondary | Differences in respiratory system compliance between patients with and without acute cor pulmonale | 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. | Within the first 24 hours of mechanical ventilation. | |
Secondary | Differences in partial arterial pressure of carbon dioxide (PCO2) between patients with and without acute cor pulmonale | Partial arterial pressure of carbon dioxide will be reported in mmHg. | Within the first 24 hours of mechanical ventilation. | |
Secondary | Differences in PaO2/FiO2 ratio between patients with and without acute cor pulmonale | 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. | Within the first 24 hours of mechanical ventilation. |
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