Assessing acute and late developing heart function in patients with sepsis and septic shock with cardiac ultrasound
| ISRCTN | ISRCTN13837507 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13837507 |
| IRAS number | 247448 |
| Secondary identifying numbers | CPMS 46556, IRAS 247448 |
- Submission date
- 19/11/2020
- Registration date
- 07/12/2020
- Last edited
- 11/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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?
December 2020 to February 2024
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
Contact information
Scientific
c/o Cardiology Outpatients
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 (0)7841477406 |
|---|---|
| emma.lane@porthosp.nhs.uk |
Public
Research Department
Portsmouth Hospitals University NHS Trust
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
| Ian.Gedge@porthosp.nhs.uk |
Study information
| Study design | Non-randomized cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | ISRCTN13837507_PIS_v3.0.pdf |
| 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. |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 01/09/2018 |
| Overall study end date | 29/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 108; UK Sample Size: 108 |
| Total final enrolment | 118 |
| 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 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 | 01/04/2021 |
| Recruitment end date | 28/02/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Research & Innovation
1st Floor Lancaster House
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
United Kingdom
| Phone | +44 (0)2328286000 |
|---|---|
| alice.mortlock@porthosp.nhs.uk | |
| Website | http://www.porthosp.nhs.uk/ |
"ROR" |
https://ror.org/009fk3b63 |
Funders
Funder type
Industry
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v3.0 | 07/12/2020 | No | Yes | |
| Protocol file | version v1.0 | 01/06/2020 | 07/12/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN13837507_PIS_v3.0.pdf
- Uploaded 07/12/2020
- ISRCTN13837507_PROTOCOL_v1.0_01Jun2020.pdf
- Uploaded 07/12/2020
Editorial Notes
11/05/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/05/2023 to 29/02/2024.
2. The intention to publish date was changed from 30/09/2023 to 30/09/2024.
3. The plain English summary was updated to reflect these changes.
07/03/2023: Total final enrolment added.
12/12/2022: The following changes have been made:
1. A public contact has been added.
2. The intention to publish date has been changed from 30/04/2023 to 30/09/2023.
08/12/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/12/2022 to 28/02/2023.
2. The overall trial end date has been changed from 01/12/2022 to 31/05/2023 and the plain English summary updated accordingly.
02/03/2021: The recruitment start date was changed from 01/03/2021 to 01/04/2021.
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).
