Right Ventricular Dysfunction in Ventilated Patients With COVID-19

Covid19 Clinical Trial

— COVID-RV  

Official title:

Right Ventricular Dysfunction in Ventilated Patients With COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04764032
• Other study ID #: 20/COVID/17
• Status: Recruiting
• Start date: September 2, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2021
• Source: University of Glasgow
• Contact: Ben Shelley, MD
• Phone: 01419515000
• Email: benjamin.shelley[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Using echocardiography to investigate the incidence of RV dysfunction in ventilated patients with COVID-19.

Description:

INTRODUCTION Following the first reported cases in China, there has been a worldwide pandemic of a new virus commonly known as, Coronavirus. The virus causes a number of conditions including; cough, high temperature, painful muscles and breathing difficulties. The disease the virus causes is known as Coronavirus Disease 2019 (COVID-19). In the majority of cases these symptoms will get better without any treatment and without needing admission to hospital. In a small proportion of cases, the symptoms can be so bad that patients will need admission to hospital. Of the group admitted to hospital an even smaller group (approximately 5% of all confirmed coronavirus cases) will need treatment in an intensive care unit. This is often for severe breathing difficulties and sometimes requires the patient to be put on a breathing machine. The breathing machine is also known as a life support machine or ventilator and needing its support is known as 'ventilation' or 'being ventilated'.

In other conditions causing severe breathing difficulties requiring ventilation, pressure can be put on the right side of the heart ('the right heart [or right ventricle];' the part of the heart pumping blood to the lungs). This can cause the right heart to fail, struggling to pump blood forward and with a build-up of back pressure. This is also known as right heart (or ventricular) dysfunction. Patients needing ventilated, who develop problems with the right heart, are less likely to survive their intensive care stay. No scientists have examined whether patients with COVID-19, requiring ventilation, have problems with their right heart.

METHODS Using noninvasive ultrasound scans of the heart (echocardiography) the investigators will explore whether ventilated patients in intensive care have problems with their right heart. The investigators will also collect blood samples to look for damage to the heart during this time.

AIMS The aim of this study is to determine how many patients with COVID-19 needing ventilation have problems with the right heart. The investigators will explore if those patients with right heart problems are more likely to die by 30 days following their intensive care admission. By examining clinical data, the investigators will also look to see if any other conditions or treatments increase the risk of right heart problems. By identifying right heart problems in these patients, the investigators may be able to guide future studies to determine if any specific treatments targeted at protecting the right heart can improve outcomes in this patient group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Provision of informed consent.

• Age > 16 years.

• Confirmed SARS-CoV-2 infection with severe acute respiratory failure requiring tracheal intubation and positive pressure ventilation in intensive care for more than 48 hours.

Exclusion Criteria:

• Pregnancy.

• Ongoing participation in any investigational research that may undermine the scientific basis of the study.

• Prior participation in the COVID-RV study.

• Ventilated for less than 48 hours prior to study recruitment.

• Those patients requiring extra-corporeal life support for respiratory or cardiovascular failure (veno-venous [VV] or veno-arterial [VA] extra-corporeal membrane oxygenation [ECMO]).

• Patient where end of life care has been instituted and they are not expected to survive for the next 24 hours.

Related Conditions & MeSH terms

• ARDS
• Covid19
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Diagnostic Test:
• Echocardiography
Echocardiography will be undertaken by a range of appropriately competent practitioners including; intensive care clinicians, cardiologists and specialist echocardiographers. Imaging obtained will be in keeping with the protocol required for a Focused Intensive Care Echo (FICE) scan and should include ECG monitoring at all times. A focused dataset will be used to answer the primary outcome. If available and the echocardiographers competency and experience permit, further measures of RV function will be obtained at this time.

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Univeristy Hospital, Ayr	Ayr
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	Dumfries and Galloway Royal Infirmary	Dumfries
United Kingdom	University Hospital Hairmyres	East Kilbride
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Raigmore Hospital	Inverness
United Kingdom	University Hospital, Crosshouse	Kilmarnock
United Kingdom	Royal Alexandra hospital	Paisley
United Kingdom	University Hospital, Wishaw	Wishaw

Sponsors (3)

Lead Sponsor	Collaborator
University of Glasgow	Golden Jubilee National Hospital, Robertson Centre for Biostatistics

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Willder JM, McCall P, Messow CM, Gillies M, Berry C, Shelley B. Study protocol for COVID-RV: a multicentre prospective observational cohort study of right ventricular dysfunction in ventilated patients with COVID-19. BMJ Open. 2021 Jan 13;11(1):e042098. doi: 10.1136/bmjopen-2020-042098. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of RV dysfunction in ventilated patients with COVID-19	RV dysfunction will be defined as Trans Thoracic Echo (TTE) evidence of RV dilatation along with the presence of septal flattening (in systole, diastole or both).	Any timepoint from eligibility (ventilation for more than 48 hours) to 14 days following tracheal intubation and positive pressure ventilation.
Primary	Association of RV dysfunction with 30-day mortality.		Up to 30-days following intubation and intermittent positive pressure ventilation
Secondary	Association of ARDS and RV dysfunction		At time of echocardiography
Secondary	Association of micro/macro thrombi and RV dysfunction		At time of echocardiography
Secondary	The association of direct myocardial injury and RV dysfunction		At time of echocardiography
Secondary	The association of ventilation and RV dysfunction		At time of echocardiography
Secondary	Association of ARDS and 30-day mortality		Up to 30-days following intubation and intermittent positive pressure ventilation
Secondary	Association of micro/macro thrombi and 30-day mortality		Up to 30-days following intubation and intermittent positive pressure ventilation
Secondary	Association of direct myocardial injury and 30-day mortality		Up to 30-days following intubation and intermittent positive pressure ventilation
Secondary	Association of ventilation and 30-day mortality		Up to 30-days following intubation and intermittent positive pressure ventilation
Secondary	The difference in NP levels between patients with, and patients without, RV dysfunction.		At time of echocardiography
Secondary	The difference in hsTn between patients with, and patients without, RV dysfunction.		At time of echocardiography
Secondary	Association between hsTn and 30-day mortality in patients with, and patients without, RV dysfunction		Up to 30-days following intubation and intermittent positive pressure ventilation
Secondary	Association between NP levels and 30-day mortality in patients with, and patients without, RV dysfunction		Up to 30-days following intubation and intermittent positive pressure ventilation