Hemodynamic Characteristics of Patients With SARS-CoV-2

Completed

• Conditions: Shock; Left Ventricular Dysfunction; Coronavirus; SARS-CoV-2; Fluid Overload; COVID-19; Acute Respiratory Distress Syndrome; Acute Circulatory Failure

• Registration Number: NCT04337983
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2020-03-13
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-08
• Primary Completion: 2020-10-30
• Study Completion: 2020-11-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body temperature	Through study completion, an estimation of 6 months	Body temperature(°C)
Blood pressure	Through study completion, an estimation of 6 months	Blood pressure in mmHg
Pulse (heart rate)	Through study completion, an estimation of 6 months	Pulse (heart rate) in times/minute
Respiratory rate	Through study completion, an estimation of 6 months	Respiratory rate in times/minute
Data provided by transpulmonary thermodilution-CI	Through study completion, an estimation of 6 months	Cardiac index (L/min/m2)
Data provided by transpulmonary thermodilution-GEDV	Through study completion, an estimation of 6 months	Global end-diastolic volume(mL/m2)
Data provided by transpulmonary thermodilution-EVLW	Through study completion, an estimation of 6 months	Extravascular lung water (mL/kg)
Data provided by transpulmonary thermodilution-PVPI	Through study completion, an estimation of 6 months	Pulmonary vascular permeability index
Incidence of abnormal laboratory test results	Through study completion, an estimation of 6 months

Secondary Outcome Measures

Name	Time	Method
Changes of extravascular lung water measured by transpulmonary thermodilution	Change from baseline extravascular lung water at 6 months	The worst extravascular lung water
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
Correlation between the hemodynamic characteristics and 90-day mortality	Up to 90th day after inclusion
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

Trial Locations

Locations (1)

Bicetre Hospital; 🇫🇷 Paris, Val-de-Marne, France