Hemodynamic Characteristics of Patients With SARS-CoV-2

Study Overview
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Brief Summary
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The outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been declared a public health emergency of international concern. Hospitalized COVID-19-positive patients requiring ICU care is increasing along with the course of epidemic. A large number of these patients developed acute respiratory distress syndrome (ARDS) according to current data. However, the related hemodynamic characteristic has so far been rarely described.

Detailed Description
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The outbreak of COVID-19 is a worldwide concern. To our knowledge, the details of the hemodynamic characteristics of COVID-19 patients have not yet been well described. Besides, the cardiac injury was reported in about 7-17% of hospitalized patients with COVID-19 in previous Chinese publications and is much more common in patients admitted to ICU and non-survivors. However, no systematic assessment, including echocardiography evaluating the left ventricular function of these patients has been declared. In addition, extravascular lung water (EVLW) and pulmonary capillary permeability are two hall markers in ARDS patient's management, and transpulmonary thermodilution is a validated method to provide these values at the bedside. However, no study has reported the characteristic profile of these variables during ARDS caused by SARS-Cov2. A better knowledge of these characteristics would also be helpful in guiding their management.

Official Title
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Hemodynamic Characteristics of Patients With SARS-CoV-2: PiCCOVID Study

Conditions
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SARS-CoV-2, Coronavirus, COVID-19, Acute Respiratory Distress Syndrome, Shock, Acute Circulatory Failure, Left Ventricular Dysfunction, Fluid Overload

Intervention / Treatment
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* Device: Transpulmonary thermodilution
* Device: Echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed or suspected SARS-Cov2 cases Patients admitted to ICU, defined as a unit in which patients can receive vasopressors. Monitored by a transpulmonary thermodilution system (PiCCO2 (Pulsion Medical Systems, Feldkirchen, Germany) or EV1000 (Edwards Lifesciences, Irvine, United States of America). Exclusion Criteria: SARS Cov-2 Negative Refusal to participate in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transpulmonary thermodilution|Obtained by averaging the results of three thermodilution measurements. Each thermodilution is performed by injecting a bolus (15 mL) of cold saline (less than 10°C)|
|Device: Echocardiography|Daily echocardiography evaluation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature | Body temperature(°C) | Through study completion, an estimation of 6 months | 
| Blood pressure | Blood pressure in mmHg | Through study completion, an estimation of 6 months | 
| Pulse (heart rate) | Pulse (heart rate) in times/minute | Through study completion, an estimation of 6 months | 
| Respiratory rate | Respiratory rate in times/minute | Through study completion, an estimation of 6 months | 
| Data provided by transpulmonary thermodilution-CI | Cardiac index (L/min/m2) | Through study completion, an estimation of 6 months | 
| Data provided by transpulmonary thermodilution-GEDV | Global end-diastolic volume(mL/m2) | Through study completion, an estimation of 6 months | 
| Data provided by transpulmonary thermodilution-EVLW | Extravascular lung water (mL/kg) | Through study completion, an estimation of 6 months | 
| Data provided by transpulmonary thermodilution-PVPI | Pulmonary vascular permeability index | Through study completion, an estimation of 6 months | 
| Incidence of abnormal laboratory test results |  | Through study completion, an estimation of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new-onset or reversible systolic left ventricular dysfunction | Left ventricle ejection fraction, Segmental left ventricle contractility, Speckle tracking data of the left and right ventricles, Dimensions of right and left cavities and Diastolic function of left ventricle | Through study completion, an estimation of 6 months | 
| Changes of extravascular lung water measured by transpulmonary thermodilution | The worst extravascular lung water | Change from baseline extravascular lung water at 6 months | 
| Changes of pulmonary vascular permeability index measured by transpulmonary thermodilution | The worst pulmonary vascular permeability index | Change from baseline extravascular lung water at 6 months | 
| Correlation between the hemodynamic characteristics and 90-day mortality |  | Up to 90th day after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodynamic chracteristics, Transpulmonary thermodilution, Preload-dependency, Echocardiography, Extravascular lung water, Pulmonary vascular permeability index