Clinical trial NCT04764032: Right Ventricular Dysfunction in Ventilated Patients With COVID-19
Official title: Right Ventricular Dysfunction in Ventilated Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Right Ventricular Dysfunction
ARDS
Keywords: COVID-19
Right Ventricle
Echocardiography
ARDS
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Golden Jubilee National Hospital
name: Robertson Centre for Biostatistics
First posted: 2021-02-21
Enrollment: 150
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring tracheal intubation and intermittent positive pressure ventilation for COVID-19 in Scottish intensive care units

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The prevalence of RV dysfunction in ventilated patients with COVID-19
timeFrame: Any timepoint from eligibility (ventilation for more than 48 hours) to 14 days following tracheal intubation and positive pressure ventilation.
measure: Association of RV dysfunction with 30-day mortality.
timeFrame: Up to 30-days following intubation and intermittent positive pressure ventilation
Secondary outcomes:
measure: Association of ARDS and RV dysfunction
timeFrame: At time of echocardiography
measure: Association of micro/macro thrombi and RV dysfunction
timeFrame: At time of echocardiography
measure: The association of direct myocardial injury and RV dysfunction
timeFrame: At time of echocardiography
measure: The association of ventilation and RV dysfunction
timeFrame: At time of echocardiography
measure: Association of ARDS and 30-day mortality
timeFrame: Up to 30-days following intubation and intermittent positive pressure ventilation
measure: Association of micro/macro thrombi and 30-day mortality
timeFrame: Up to 30-days following intubation and intermittent positive pressure ventilation
measure: Association of direct myocardial injury and 30-day mortality
timeFrame: Up to 30-days following intubation and intermittent positive pressure ventilation
measure: Association of ventilation and 30-day mortality
timeFrame: Up to 30-days following intubation and intermittent positive pressure ventilation
measure: The difference in NP levels between patients with, and patients without, RV dysfunction.
timeFrame: At time of echocardiography
measure: The difference in hsTn between patients with, and patients without, RV dysfunction.
timeFrame: At time of echocardiography
measure: Association between hsTn and 30-day mortality in patients with, and patients without, RV dysfunction
timeFrame: Up to 30-days following intubation and intermittent positive pressure ventilation
measure: Association between NP levels and 30-day mortality in patients with, and patients without, RV dysfunction
timeFrame: Up to 30-days following intubation and intermittent positive pressure ventilation
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Ayr
country: United Kingdom
facility: Univeristy Hospital, Ayr
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Dumfries
country: United Kingdom
facility: Dumfries and Galloway Royal Infirmary
city: East Kilbride
country: United Kingdom
facility: University Hospital Hairmyres
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Kilmarnock
country: United Kingdom
facility: University Hospital, Crosshouse
city: Paisley
country: United Kingdom
facility: Royal Alexandra hospital
city: Wishaw
country: United Kingdom
facility: University Hospital, Wishaw
Study officials:
affiliation: University of Glasgow
name: Ben Shelley, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: McErlane J, McCall P, Willder J, Berry C, Shelley B; COVID-RV investigators. Right ventricular free wall longitudinal strain is independently associated with mortality in mechanically ventilated patients with COVID-19. Ann Intensive Care. 2022 Nov 12;12(1):104. doi: 10.1186/s13613-022-01077-7.