Can changes in myocardial work and right ventricle free wall strain predict 30-day mortality in critical care patients presenting with sepsis?
| ISRCTN | ISRCTN23174569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23174569 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 262520 |
| Protocol serial number | IRAS 262520 |
| Sponsor | Surrey and Sussex Healthcare NHS Trust |
| Funder | Critical Care Department, Surrey and Sussex Healthcare NHS Trust |
- Submission date
- 24/03/2021
- Registration date
- 12/04/2021
- Last edited
- 16/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Sepsis is a leading cause of death and disability in critical care units worldwide. Sepsis affects all the major organ systems within the body but it is still not fully understood how sepsis affects organs, and in particular, the heart. In sepsis, there can be varying stress placed on the heart and it may take up to 10 days to fully recover once the patient has been successfully treated. However, it is still not fully understood the initial effects that sepsis has on the heart and the stress placed on the heart may not be appropriately recognised with the current standard measures of heart function.
This study aims to measure the effects of sepsis on how much energy and stress the heart uses and generates to pump blood, using echocardiography (the same non-invasive technology that is used in pregnancy to image a mother’s baby). From these images, the study team will be able to calculate the amount of work done and strain the heart is placed under using specialized computer software. This non-invasive echocardiography is now a standard of care for patients being admitted to critical care. Using this software the study team will extract as much information as possible from the images, to hopefully help to identify patients early that may benefit from changes to their sepsis management. These analyses could be useful as they can be completed from a standard echocardiogram of the chest with no extra views or tests needed. This study also aims to compare the energy spent (or work done) by the heart in sepsis against standard measures of heart function.
Who can participate?
Adult patients admitted to critical care with a severe infection needing more organ support that can be given on normal wards.
What does the study involve?
The study involves identifying very sick patients that present to critical care with infection (sepsis) and using ultrasound to image their heart within 24 h of admission, then between 48 and 72 h after admission.
What are the possible benefits and risks of participating?
Increased surveillance of heart function on day 3 is of potential benefit as it will give greater insight into how well the heart is functioning using ultrasound. There is a very small risk of bruising associated with the placement of the probe against the chest wall, but this is transient and will resolve within hours.
Where is the study run from?
Critical Care Unit at Surrey and Sussex Healthcare NHS Trust (UK)
When is the study starting and how long is it expected to run for?
From January 2019 to December 2023
Who is funding the study?
The Critical Care Department at Surrey and Sussex Healthcare NHS Trust (UK)
Who is the main contact?
Dr Theophilus Samuels, theophilus.samuels1@nhs.net
Contact information
Public
East Surrey Hospital
Canada Avenue
Redhill
RH1 5GY
United Kingdom
 ORCID ID |
0000-0003-1986-9024 |
|---|---|
| Phone | +44 (0)1737 768511 |
| theophilus.samuels1@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre prospective observational cohort pilot study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | myoCardial work and Right ventricle Strain In Sepsis (CRiSIS): new investigations in critical care echocardiography |
| Study acronym | CRiSIS |
| Study objectives | Current study hypothesis as of 18/10/2024: As no specific data are available on the assessment of myocardial work (MW) and minimal data on right ventricle free wall strain (RV FWS) in patients presenting with sepsis to critical care, this study aimed to: 1. Investigate if MW and RV FWS measured on days 1 and 3 of admission are associated with 30-day mortality 2. Investigate if any association exists between the interval changes (i.e. the difference in measurements recorded on day 1 and day 3 of their admission) in MW and RV FWS on 30-day mortality 3. Assess if any differences exist on day 1 between male and female patients in MW and RV FWS 4. Provide insights into the degree to which myocardial work and RV FWS are associated with Global Longitudinal Strain (GLS) and left ventricular ejection fraction (LVEF) Previous study hypothesis: 1. Measuring how much work the heart uses to interrogate cardiac function and determine if changes over a 72 h period can help to predict mortality at 30 days 2. Right ventricle free wall strain (RVFWS), the strain that the right ventricle is placed under when it beats), will also add further evidence to our currently limited knowledge on the association between sepsis and RVFWS 3. Comparing the left ventricle strain and right-side free wall strain against each other may demonstrate an interactive effect due to the phenomenon of ventricular interdependence 4. To create a model to predict the outcomes in patients presenting with sepsis for validation in future studies, in the hope that it can be used to improve outcomes and treatment strategies |
| Ethics approval(s) |
Approved 12/05/2021, London Bromley Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; approvals@hra.nhs.uk), ref: 21/LO/0303 |
| Health condition(s) or problem(s) studied | Critical care patients admitted with sepsis |
| Intervention | Current interventions as of 21/10/2024: Participant hearts will be examined using standard transthoracic echocardiogram (TTE) on 1 and 3 days of admission to ICU. From these images, the study team will be able to calculate the amount of work done by the heart muscle and strain the heart is placed under using specialized computer software. Non-invasive echocardiography is now a standard of care for patients being admitted to critical care. By using this software, the study team will extract as much information as possible from the echocardiography, which will hopefully help to identify patients early that may benefit from changes to their sepsis management. The study team also wishes to compare the energy spent (or work done) by the heart in sepsis against standard parameters of heart function. It has recently been shown that these correlate well in healthy patients, and therefore, it is important to assess if this correlation persists in sepsis. Lastly, what is favourable about these analyses is that they can be completed from a standard transthoracic echocardiogram (TTE) with no extra views or tests needed. They are in effect, tasks that can be done on a computer. In addition, this measurement is less load-dependent than other standard measures used (it does not depend that much on external factors that can reduce the ability of the heart to pump blood, such as a very high blood pressure). Previous interventions: Participant hearts will be examined using standard transthoracic echocardiogram (TTE) on 1, 3, and 90 days of admission to ICU. From these images, the study team will be able to calculate the amount of work done by the heart muscle and strain the heart is placed under using specialized computer software. Non-invasive echocardiography is now a standard of care for patients being admitted to critical care. By using this software, the study team will extract as much information as possible from the echocardiography, which will hopefully help to identify patients early that may benefit from changes to their sepsis management. The study team also wishes to compare the energy spent (or work done) by the heart in sepsis against standard parameters of heart function. It has recently been shown that these correlate well in healthy patients, and therefore, it is important to assess if this correlation persists in sepsis. Lastly, what is favourable about these analyses is that they can be completed from a standard transthoracic echocardiogram (TTE) with no extra views or tests needed. They are in effect, tasks that can be done on a computer. In addition, this measurement is less load-dependent than other standard measures used (it does not depend that much on external factors that can reduce the ability of the heart to pump blood, such as a very high blood pressure). |
| Intervention type | Other |
| Primary outcome measure(s) |
Current primary outcome measure as of 21/10/2024: |
| Key secondary outcome measure(s) |
Previous secondary outcome measures as of 21/10/2024: |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 39 |
| Key inclusion criteria | 1. Aged ≥18 years 2. Admission diagnosis of sepsis 3. Standard of care echocardiogram within 24 h of admission to ICU 4. Adequate echocardiography image quality that permits cardiac work analysis and/or strain assessment of the right ventricle free wall 5. Able to speak, understand and communicate in English 6. Written or verbal informed consent from the patient or next of kin |
| Key exclusion criteria | 1. Atrial fibrillation 2. Previous cardiac surgery 3. Pregnancy 4. Severe valvular disease 5. Inadequate echocardiography image quality |
| Date of first enrolment | 01/05/2021 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Canada Avenue
Redhill
Surrey
RH1 5RH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/05/2025 | 16/07/2025 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/07/2025: Publication reference added.
21/10/2024: The following changes were made:
1. The public title was changed from "Can changes between days 1 and 3 in cardiac work and right ventricle free wall strain predict 30-day mortality in critical care patients presenting with sepsis?"
2. The scientific title was changed from "Can changes between days 1 and 3 in cardiac work and right ventricle free wall strain predict 30-day mortality in critical care patients presenting with sepsis?".
3. Study hypothesis, interventions, and primary and secondary outcome measures were updated.
4. Study design was changed from "Observational cohort study".
5. The target number of participants was changed from 100 to 50.
6. Total final enrolment was added.
7. The intention to publish date was changed from 30/04/2024 to 30/12/2024.
01/08/2023: The recruitment end date has been changed from 31/12/2022 to 31/12/2023.
13/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2022 to 31/12/2023.
2. The intention to publish date was changed from 01/08/2023 to 30/04/2024.
3. The plain English summary was updated to reflect these changes.
23/05/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/05/2022 to 31/12/2022.
2. The overall end date was changed from 01/08/2022 to 31/12/2022.
3. The plain English summary was updated to reflect these changes.
03/06/2021: The ethics approval has been added.
12/04/2021: Trial’s existence confirmed by London – Bromley REC.
