Condition category
Circulatory System
Date applied
19/11/2020
Date assigned
07/12/2020
Last edited
04/01/2021
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
This study aims to investigate if new ultrasound techniques together with blood samples may help to detect heart failure sooner than current methods in patients who are in the Intensive Care Unit with sepsis or septic shock. The study will also involve follow up with further ultrasound scans and blood tests after patients have recovered to see if more information can be found on what happens to heart function after leaving the hospital. This has not been investigated before.

Who can participate?
Any adults meeting the inclusion criteria of sepsis or septic shock while a patient within the participating centre critical care unit, and without meeting any exclusion criteria.

What does the study involve?
The study involves blood tests and ultrasound scans of the heart at 4 different times over 90 days and a phone call to participants 1 year after starting the study.

What are the possible benefits and risks of participating?
There are no benefits to participation aside from having regular heart scans which may pick up incidental findings

Where is the study run from?
Queen Alexandra Hospital, Portsmouth Hospitals University Trust (UK)

When is the study starting and how long is it expected to run for?
From December 2020 to December 2022

Who is funding the study?
AMBU Ltd (UK), Cardiac Remotes Ltd (UK), and the National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Mrs Emma Lane
emma.lane@porthosp.nhs.uk

Trial website

http://www.GLASSheartstudy.co.uk

Contact information

Type

Scientific

Primary contact

Mrs Emma Lane

ORCID ID

Contact details

c/o Cardiology Outpatients
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
+44 (0)7841477406
emma.lane@porthosp.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 46556, IRAS 247448

Study information

Scientific title

The assessment of left ventricular function in septic shock; comparison of ejection fraction measurement (both by two dimensional and three dimensional echocardiography), global longitudinal strain, high sensitivity troponin and pro NtBNP.

Acronym

GLASSheart

Study hypothesis

1. To extend knowledge since re-classification of sepsis and septic shock (Sepsis 3 criteria)
2. To improve early diagnosis of septic cardiomyopathy in the critical care population using newer echocardiographic techniques such as Global Longitudinal Strain (GLS)
3. To investigate if decreased GLS can identify patients who are at risk of progressive left ventricular dysfunction (assessed by echocardiogram at 90 days) and major adverse cardiovascular events (assessed at 1 year)
4. To evaluate whether established biomarkers add additional clinical utility.

Ethics approval

Approved 13/10/2020, East of England – Cambridge Central Research Ethics Committee (Royal Standard Place, Nottingham, NG1 6FS; +44 (0)2071048384; cambridgecentral.rec@hra.nhs.uk), ref: 20/EE/0209

Study design

Non-randomized cohort study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

See additional file ISRCTN13837507_PIS_v3.0

Condition

Left ventricular function in septic shock

Intervention

GLASSheart is a cohort study. Within the first 24 h, the study team will obtain consent to participate and then start to collect demographic and basic physiological data from participants (this data is standard routine care for the monitoring of the critically unwell patient) including ventilator settings, estimated or actual weight, urine analysis, ECG (electrical tracing of heart activity), and blood pressure and vital signs.

The study data collection of 2D echo, 3D echo, GLS, and both biomarker blood tests are additional procedures/tests and occur in the following time periods:
1. 1st scan at 24 h including echo scans (2D, 3D, and GLS) and blood tests (high sensitivity Troponin and Pro NT BNP)
2. 2nd scan at 48-72 h including repeat echo scans (2D, 3D, and GLS) only
3. 3rd scan at 30 days (+/- 5 days) including repeat echo scans (2D, 3D, and GLS) and blood tests (high sensitivity Troponin and Pro NT BNP)
4. 4th Scan at 90 days (+/- 5 days) including repeat echo scans (2D, 3D, and GLS) and blood tests (high sensitivity Troponin and Pro NT BNP)

It is assumed that most participants will have been discharged from critical care by ≥30 days. In this case, they will be contacted by telephone to be offered follow-up appointments for the 3rd and 4th scans and blood tests. If participants remain within the hospital at 30 and 90 days, then the assessment can be done in the hospital.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Left ventricular function measured using:
1.1. Echocardiography: two-dimensional ejection fraction calculation (2D EF), three-dimensional ejection fraction (3D EF), and global longitudinal strain (GLS), at 24 h, 72 h, 30 days, and 90 days
1.2. Peripheral venous blood tests to identify troponin (high sensitivity assay- HS TROP), and B-type natriuretic peptides (BNP) at 24 h, 30 days, and 90 days

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/09/2018

Overall trial end date

01/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18-85 years inclusive
2. Sepsis or septic shock (defined by Third International Consensus Definitions for Sepsis and Septic Shock)
3. Admission to the Intensive Care Unit (ICU)
4. Consent to inclusion or favourable opinion for inclusion from consultee

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 108; UK Sample Size: 108

Participant exclusion criteria

1. Pregnancy or complications thereof
2. End-Stage Renal Failure (ESRF) requiring dialysis, or Chronic Kidney Disease (CKD) with eGFR <30 ml/min
3. Cardiac transplant recipient
4. Uncorrected valvular dysfunction (graded as moderate or severe)
5. Known structural heart disease
6. Pre-existing cardiomyopathy with bundle block on electrocardiogram (ECG)
7. Previous cardiac valve replacement
8. Post-operative within last 7 days
9. Atrial fibrillation/flutter or frequent ventricular ectopic beats during image acquisition
10. Death likely within 24 h in the opinion of the assessing clinician

Recruitment start date

01/03/2021

Recruitment end date

01/12/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Portsmouth Hospitals NHS Trust
De La Court House Queen Alexandra Hospital Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Portsmouth Hospitals NHS Trust

Sponsor details

c/o Research & Innovation
1st Floor Lancaster House
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
+44 (0)2328286000
alice.mortlock@porthosp.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.porthosp.nhs.uk/

Funders

Funder type

Industry

Funder name

AMBU Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

Cardiac Remotes Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/04/2023

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/01/2021: The recruitment start date was changed from 15/01/2021 to 01/03/2021. 07/12/2020: Uploaded protocol version 1.0, 01 June 2020 (not peer reviewed). 19/11/2020: Trial’s existence confirmed by the National Institute for Health Research (NIHR).