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

Sponsor
Bicetre Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04337983
Collaborator
(none)
60
1
8.6
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transpulmonary thermodilution
  • Device: Echocardiography

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 Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Hemodynamic Characteristics of Patients With SARS-CoV-2: PiCCOVID Study
Actual Study Start Date :
Mar 13, 2020
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Outcome Measures

Primary Outcome Measures

  1. Body temperature [Through study completion, an estimation of 6 months]

    Body temperature(°C)

  2. Blood pressure [Through study completion, an estimation of 6 months]

    Blood pressure in mmHg

  3. Pulse (heart rate) [Through study completion, an estimation of 6 months]

    Pulse (heart rate) in times/minute

  4. Respiratory rate [Through study completion, an estimation of 6 months]

    Respiratory rate in times/minute

  5. Data provided by transpulmonary thermodilution-CI [Through study completion, an estimation of 6 months]

    Cardiac index (L/min/m2)

  6. Data provided by transpulmonary thermodilution-GEDV [Through study completion, an estimation of 6 months]

    Global end-diastolic volume(mL/m2)

  7. Data provided by transpulmonary thermodilution-EVLW [Through study completion, an estimation of 6 months]

    Extravascular lung water (mL/kg)

  8. Data provided by transpulmonary thermodilution-PVPI [Through study completion, an estimation of 6 months]

    Pulmonary vascular permeability index

  9. Incidence of abnormal laboratory test results [Through study completion, an estimation of 6 months]

Secondary Outcome Measures

  1. Incidence of new-onset or reversible systolic left ventricular dysfunction [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

  2. Changes of extravascular lung water measured by transpulmonary thermodilution [Change from baseline extravascular lung water at 6 months]

    The worst extravascular lung water

  3. Changes of pulmonary vascular permeability index measured by transpulmonary thermodilution [Change from baseline extravascular lung water at 6 months]

    The worst pulmonary vascular permeability index

  4. Correlation between the hemodynamic characteristics and 90-day mortality [Up to 90th day after inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bicetre Hospital Paris Val-de-Marne France 94270

Sponsors and Collaborators

  • Bicetre Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xavier Monnet, Professor Xavier Monnet MD. PhD., Bicetre Hospital
ClinicalTrials.gov Identifier:
NCT04337983
Other Study ID Numbers:
  • 2020-A00793-36
First Posted:
Apr 8, 2020
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xavier Monnet, Professor Xavier Monnet MD. PhD., Bicetre Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2021