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Hemodynamic Characteristics of Patients With SARS-CoV-2

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04337983
Acronym
PiCCOVID
Enrollment
60
Registered
2020-04-08
Start date
2020-03-13
Completion date
2020-11-30
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Hemodynamic chracteristics, Transpulmonary thermodilution, Preload-dependency, Echocardiography, Extravascular lung water, Pulmonary vascular permeability index

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.

Interventions

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)

DEVICEEchocardiography

Daily echocardiography evaluation

Sponsors

Bicetre Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of abnormal laboratory test resultsThrough study completion, an estimation of 6 months
Data provided by transpulmonary thermodilution-CIThrough study completion, an estimation of 6 monthsCardiac index (L/min/m2)
Data provided by transpulmonary thermodilution-GEDVThrough study completion, an estimation of 6 monthsGlobal end-diastolic volume(mL/m2)
Data provided by transpulmonary thermodilution-EVLWThrough study completion, an estimation of 6 monthsExtravascular lung water (mL/kg)
Data provided by transpulmonary thermodilution-PVPIThrough study completion, an estimation of 6 monthsPulmonary vascular permeability index
Body temperatureThrough study completion, an estimation of 6 monthsBody temperature(°C)
Blood pressureThrough study completion, an estimation of 6 monthsBlood pressure in mmHg
Pulse (heart rate)Through study completion, an estimation of 6 monthsPulse (heart rate) in times/minute
Respiratory rateThrough study completion, an estimation of 6 monthsRespiratory rate in times/minute

Secondary

MeasureTime frameDescription
Changes of extravascular lung water measured by transpulmonary thermodilutionChange from baseline extravascular lung water at 6 monthsThe worst extravascular lung water
Changes of pulmonary vascular permeability index measured by transpulmonary thermodilutionChange from baseline extravascular lung water at 6 monthsThe worst pulmonary vascular permeability index
Correlation between the hemodynamic characteristics and 90-day mortalityUp to 90th day after inclusion
Incidence of new-onset or reversible systolic left ventricular dysfunctionThrough study completion, an estimation of 6 monthsLeft 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026