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Covid19COVID-RVNCT04764032

Right Ventricular Dysfunction in Ventilated Patients With COVID-19

An observational study of Covid19 and Right Ventricular Dysfunction, run by University of Glasgow at 11 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Using echocardiography to investigate the incidence of RV dysfunction in ventilated patients with COVID-19. Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
Covid19, Right Ventricular Dysfunction, ARDS
What is being tested?
Echocardiography
How many people
150 participants
Where
11 sitesUnited Kingdom
Study dates
2 Sep 2020to 30 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients requiring tracheal intubation and intermittent positive pressure ventilation for COVID-19 in Scottish intensive care units

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country.

Ben Shelley, MD contact

01419515000 ext. 4293

benjamin.shelley@glasgow.ac.uk

Philip McCall, MD contact

01419515000 ext. 4293

philipmccall@nhs.net

11 sites in 1 country

United Kingdom11 sites, 11 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

    James MacBrayne

    James MacBrayne

    Recruiting

  • Univeristy Hospital, Ayr

    Ayr, KA6 6DX

    Derek McLaughlan

    Derek McLaughlan

    Recruiting

  • Golden Jubilee National Hospital

    Clydebank

    Ben Shelley, MD, 0141 9515000 ext. 4293, b.shelley@clinmed.gla.ac.uk

    Ben Shelley, MD

    Recruiting

  • Dumfries and Galloway Royal Infirmary

    Dumfries, DG2 8RX

    Alexander McDonald

    Alexander McDonald

    Recruiting

  • University Hospital Hairmyres

    East Kilbride, G75 8RG

    Nina Tatarkowska, MBChB

    Nina Tatarkowska, MBChB

    Recruiting

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

    Malcolm Sim, MD

    Malcolm Sim, MD

    Recruiting

  • Glasgow Royal Infirmary

    Glasgow

    Alex Puxty, MBChB

    Alex Puxty, MBChB

    Recruiting

  • Raigmore Hospital

    Inverness, IV2 3JH

    Benjamin Greatorex

    Benjamin Greatorex

    Recruiting

  • University Hospital, Crosshouse

    Kilmarnock, KA2 0BE

    John Allan

    John Allan

    Recruiting

  • Royal Alexandra hospital

    Paisley, PA2 9PJ

    Lisa Gemmell, MBChB

    Lisa Gemmell, MBChB

    Recruiting

  • University Hospital, Wishaw

    Wishaw, ML2 0DP

    Dominic Strachan, MBChB

    Dominic Strachan, MBChB

    Recruiting

Other trials in United Kingdom

About this study

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

Read the 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.

Being tested
Echocardiography
Keywords
COVID-19, Right Ventricle, Echocardiography, ARDS
Medical subject headings
COVID-19, Ventricular Dysfunction, Right

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EchocardiographyDiagnostic test

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Any timepoint from eligibility (ventilation for more than 48 hours) to 14 days following tracheal intubation and positive pressure ventilation.

  2. Association of RV dysfunction with 30-day mortality.

    Measured: Up to 30-days following intubation and intermittent positive pressure ventilation

Secondary outcomes (12)

  1. Association of ARDS and RV dysfunction

    Measured: At time of echocardiography

  2. Association of micro/macro thrombi and RV dysfunction

    Measured: At time of echocardiography

  3. The association of direct myocardial injury and RV dysfunction

    Measured: At time of echocardiography

  4. The association of ventilation and RV dysfunction

    Measured: At time of echocardiography

  5. Association of ARDS and 30-day mortality

    Measured: Up to 30-days following intubation and intermittent positive pressure ventilation

  6. Association of micro/macro thrombi and 30-day mortality

    Measured: Up to 30-days following intubation and intermittent positive pressure ventilation

  7. Association of direct myocardial injury and 30-day mortality

    Measured: Up to 30-days following intubation and intermittent positive pressure ventilation

  8. Association of ventilation and 30-day mortality

    Measured: Up to 30-days following intubation and intermittent positive pressure ventilation

  9. The difference in NP levels between patients with, and patients without, RV dysfunction.

    Measured: At time of echocardiography

  10. The difference in hsTn between patients with, and patients without, RV dysfunction.

    Measured: At time of echocardiography

  11. Association between hsTn and 30-day mortality in patients with, and patients without, RV dysfunction

    Measured: Up to 30-days following intubation and intermittent positive pressure ventilation

  12. Association between NP levels and 30-day mortality in patients with, and patients without, RV dysfunction

    Measured: Up to 30-days following intubation and intermittent positive pressure ventilation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start2 Sep 2020
  3. Primary completion31 Mar 2021 (estimated)
  4. Study completion30 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04764032
Sponsor's protocol ID
20/COVID/17
Acronym
COVID-RV
Status last verified
Feb 2021
First submitted
12 Feb 2021
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33441361

  • 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.

    PubMed 36370220

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Right Ventricular Dysfunction, run by University of Glasgow at 11 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ben Shelley, MD (01419515000 ext. 4293, benjamin.shelley@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevalence of RV dysfunction in ventilated patients with COVID-19 (time frame: Any timepoint from eligibility (ventilation for more than 48 hours) to 14 days following tracheal intubation and positive pressure ventilation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04764032, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.

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COVID-RV Clinical Trial NCT04764032 | AzTrials