Hemodynamic Characteristics of Patients With SARS-CoV-2

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

Sponsors

Lead Sponsor: Bicetre Hospital

Source Bicetre Hospital
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.

Overall Status Completed
Start Date 2020-03-13
Completion Date 2020-11-30
Primary Completion Date 2020-10-30
Study Type Observational
Primary Outcome
Measure Time Frame
Body temperature Through study completion, an estimation of 6 months
Blood pressure Through study completion, an estimation of 6 months
Pulse (heart rate) Through study completion, an estimation of 6 months
Respiratory rate Through study completion, an estimation of 6 months
Data provided by transpulmonary thermodilution-CI Through study completion, an estimation of 6 months
Data provided by transpulmonary thermodilution-GEDV Through study completion, an estimation of 6 months
Data provided by transpulmonary thermodilution-EVLW Through study completion, an estimation of 6 months
Data provided by transpulmonary thermodilution-PVPI Through study completion, an estimation of 6 months
Incidence of abnormal laboratory test results Through study completion, an estimation of 6 months
Secondary Outcome
Measure Time Frame
Incidence of new-onset or reversible systolic left ventricular dysfunction Through study completion, an estimation of 6 months
Changes of extravascular lung water measured by transpulmonary thermodilution Change from baseline extravascular lung water at 6 months
Changes of pulmonary vascular permeability index measured by transpulmonary thermodilution Change from baseline extravascular lung water at 6 months
Correlation between the hemodynamic characteristics and 90-day mortality Up to 90th day after inclusion
Enrollment 60
Condition
Intervention

Intervention Type: Device

Intervention Name: Transpulmonary thermodilution

Description: 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)

Intervention Type: Device

Intervention Name: Echocardiography

Description: Daily echocardiography evaluation

Eligibility

Sampling Method:

Probability Sample

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Xavier Monnet, MD.PhD

Phone: +33 01 45 21 35 39

Email: [email protected]

Location
Facility: Bicetre Hospital
Location Countries

France

Verification Date

2021-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Bicetre Hospital

Investigator Full Name: Xavier Monnet

Investigator Title: Professor Xavier Monnet MD. PhD.

Keywords
Has Expanded Access No
Condition Browse
Acronym PiCCOVID
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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