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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04337983
Recruitment Status : Not yet recruiting
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Xavier Monnet, 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.

Condition or disease Intervention/treatment
Coronavirus SARS-CoV-2 COVID-19 Acute Respiratory Distress Syndrome Shock Acute Circulatory Failure Left Ventricular Dysfunction Fluid Overload 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodynamic Characteristics of Patients With SARS-CoV-2: PiCCOVID Study
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021



Intervention Details:
  • Device: Transpulmonary thermodilution
    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)
  • Device: Echocardiography
    Daily echocardiography evaluation


Primary Outcome Measures :
  1. Body temperature [ Time Frame: Through study completion, an estimation of 6 months ]
    Body temperature(°C)

  2. Blood pressure [ Time Frame: Through study completion, an estimation of 6 months ]
    Blood pressure in mmHg

  3. Pulse (heart rate) [ Time Frame: Through study completion, an estimation of 6 months ]
    Pulse (heart rate) in times/minute

  4. Respiratory rate [ Time Frame: Through study completion, an estimation of 6 months ]
    Respiratory rate in times/minute

  5. Data provided by transpulmonary thermodilution-CI [ Time Frame: Through study completion, an estimation of 6 months ]
    Cardiac index (L/min/m2)

  6. Data provided by transpulmonary thermodilution-GEDV [ Time Frame: Through study completion, an estimation of 6 months ]
    Global end-diastolic volume(mL/m2)

  7. Data provided by transpulmonary thermodilution-EVLW [ Time Frame: Through study completion, an estimation of 6 months ]
    Extravascular lung water (mL/kg)

  8. Data provided by transpulmonary thermodilution-PVPI [ Time Frame: Through study completion, an estimation of 6 months ]
    Pulmonary vascular permeability index

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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

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


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
SARS-Cov2 positive patients admitted to ICU and monitored by transpulmonary thermodilution system will be included.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337983


Contacts
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Contact: Xavier Monnet, MD.PhD +33 01 45 21 35 39 xavier.monnet@aphp.fr

Locations
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France
Bicetre Hospital
Paris, Val-de-Marne, France, 94270
Sponsors and Collaborators
Bicetre Hospital
Publications:

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Responsible Party: Xavier Monnet, Professor Xavier Monnet MD. PhD., Bicetre Hospital
ClinicalTrials.gov Identifier: NCT04337983    
Other Study ID Numbers: 2020-A00793-36
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xavier Monnet, Bicetre Hospital:
Hemodynamic chracteristics
Transpulmonary thermodilution
Preload-dependency
Echocardiography
Extravascular lung water
Pulmonary vascular permeability index
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Ventricular Dysfunction
Ventricular Dysfunction, Left
Shock
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Heart Diseases
Cardiovascular Diseases
Pathologic Processes