Clinical trial NCT04337983: Hemodynamic Characteristics of Patients With SARS-CoV-2
Official title: Hemodynamic Characteristics of Patients With SARS-CoV-2: PiCCOVID Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
SARS-CoV-2
COVID-19
Acute Respiratory Distress Syndrome
Shock
Acute Circulatory Failure
Left Ventricular Dysfunction
Fluid Overload
Keywords: Hemodynamic chracteristics
Transpulmonary thermodilution
Preload-dependency
Echocardiography
Extravascular lung water
Pulmonary vascular permeability index
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SARS-Cov2 positive patients admitted to ICU and monitored by transpulmonary thermodilution system will be included.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body temperature
timeFrame: Through study completion, an estimation of 6 months
measure: Blood pressure
timeFrame: Through study completion, an estimation of 6 months
measure: Pulse (heart rate)
timeFrame: Through study completion, an estimation of 6 months
measure: Respiratory rate
timeFrame: Through study completion, an estimation of 6 months
measure: Data provided by transpulmonary thermodilution-CI
timeFrame: Through study completion, an estimation of 6 months
measure: Data provided by transpulmonary thermodilution-GEDV
timeFrame: Through study completion, an estimation of 6 months
measure: Data provided by transpulmonary thermodilution-EVLW
timeFrame: Through study completion, an estimation of 6 months
measure: Data provided by transpulmonary thermodilution-PVPI
timeFrame: Through study completion, an estimation of 6 months
measure: Incidence of abnormal laboratory test results
timeFrame: Through study completion, an estimation of 6 months
Secondary outcomes:
measure: Incidence of new-onset or reversible systolic left ventricular dysfunction
timeFrame: Through study completion, an estimation of 6 months
measure: Changes of extravascular lung water measured by transpulmonary thermodilution
timeFrame: Change from baseline extravascular lung water at 6 months
measure: Changes of pulmonary vascular permeability index measured by transpulmonary thermodilution
timeFrame: Change from baseline extravascular lung water at 6 months
measure: Correlation between the hemodynamic characteristics and 90-day mortality
timeFrame: Up to 90th day after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Bicetre Hospital
state: Val-de-Marne
Study officials:
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