Skip to main content
OpenTrials
Completed

NCT Number: NCT04337983

Hemodynamic Characteristics of Patients With SARS-CoV-2

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronavirus Acute Circulatory Failure Acute Respiratory Distress Syndrome COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Edema Fluid Overload Heart Diseases Infections Left Ventricular Dysfunction Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Shock Signs and Symptoms Ventricular Dysfunction Ventricular Dysfunction, Left Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Bicetre Hospital

Paris, Val-de-Marne, 94270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transpulmonary thermodilution

Device

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)

Echocardiography

Device

Daily echocardiography evaluation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bicetre Hospital

Other

Registry information

Official study title

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

Acronym: PiCCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2020
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.