Hemodynamic Characteristics of Patients With SARS-CoV-2 (PiCCOVID)

September 13, 2021 updated by: Xavier Monnet, Bicetre Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val-de-Marne
      • Paris, Val-de-Marne, France, 94270
        • Bicetre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

SARS-Cov2 positive patients admitted to ICU and monitored by transpulmonary thermodilution system will be included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body temperature
Time Frame: Through study completion, an estimation of 6 months
Body temperature(°C)
Through study completion, an estimation of 6 months
Blood pressure
Time Frame: Through study completion, an estimation of 6 months
Blood pressure in mmHg
Through study completion, an estimation of 6 months
Pulse (heart rate)
Time Frame: Through study completion, an estimation of 6 months
Pulse (heart rate) in times/minute
Through study completion, an estimation of 6 months
Respiratory rate
Time Frame: Through study completion, an estimation of 6 months
Respiratory rate in times/minute
Through study completion, an estimation of 6 months
Data provided by transpulmonary thermodilution-CI
Time Frame: Through study completion, an estimation of 6 months
Cardiac index (L/min/m2)
Through study completion, an estimation of 6 months
Data provided by transpulmonary thermodilution-GEDV
Time Frame: Through study completion, an estimation of 6 months
Global end-diastolic volume(mL/m2)
Through study completion, an estimation of 6 months
Data provided by transpulmonary thermodilution-EVLW
Time Frame: Through study completion, an estimation of 6 months
Extravascular lung water (mL/kg)
Through study completion, an estimation of 6 months
Data provided by transpulmonary thermodilution-PVPI
Time Frame: Through study completion, an estimation of 6 months
Pulmonary vascular permeability index
Through study completion, an estimation of 6 months
Incidence of abnormal laboratory test results
Time Frame: Through study completion, an estimation of 6 months
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
Time Frame: Through study completion, an estimation of 6 months
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
Time Frame: Change from baseline extravascular lung water at 6 months
The worst extravascular lung water
Change from baseline extravascular lung water at 6 months
Changes of pulmonary vascular permeability index measured by transpulmonary thermodilution
Time Frame: Change from baseline extravascular lung water at 6 months
The worst pulmonary vascular permeability index
Change from baseline extravascular lung water at 6 months
Correlation between the hemodynamic characteristics and 90-day mortality
Time Frame: Up to 90th day after inclusion
Up to 90th day after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bicetre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 13, 2020

Primary Completion (ACTUAL)

October 30, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 3, 2020

First Posted (ACTUAL)

April 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00793-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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