Can a lactate measurement taken during out of hospital cardiac arrest predict the patient's survival to hospital?
| ISRCTN | ISRCTN24519917 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24519917 |
| IRAS number | 271249 |
| Secondary identifying numbers | 02072019, IRAS 271249 |
- Submission date
- 16/02/2020
- Registration date
- 18/02/2020
- Last edited
- 31/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
A cardiac arrest occurs when the heart suddenly stops beating. NHS ambulance services attend approximately 30,000 such incidents annually to provide a treatment called resuscitation. Despite the efforts of the ambulance services, less than one in ten people survive.
When a patient's heart stops their body becomes deprived of oxygen. This lack of oxygen results in a rise of lactic acid (lactate) which, when present in sufficient levels, has been proven can predict the patient's likelihood of survival. The research to find this out was conducted in hospital but there is no evidence to suggest that lactate measured in the ambulance would produce the same results. It is possible to measure lactate accurately and rapidly in the ambulance using a small sample of blood and a small hand-held device. Results are available within seconds and may be valuable to the paramedic when making decisions regarding treatment.
This research will test if lactate readings taken during a resuscitation attempt by a paramedic can predict a patient's likelihood of surviving to hospital. The researchers will do this by looking at data already collected by the ambulance service. In addition to the lactate readings all patients will continue to receive normal treatments.
Who can participate?
Persons aged 18 years and older who are eligible for resuscitation in accordance with current Resuscitation Council guidelines.
What does the study involve?
The study involves collecting blood lactate measurements from adult patients suffering a medical out of hospital cardiac arrest. Data will be collected in the field by study trained paramedics and reported to the research team. The researchers will then correlate the lactate measurements for individual patients with specifics about each event and individual outcomes.
What are the possible benefits and risks of participating?
The benefits of participating in this study are that participants will be contributing towards our understanding of lactate in out of hospital cardiac arrest and if a lactate measurement is prognostic of survival. Any risks should be minimal. All participants will continue to receive standard care as a result of being involved in this study and study involvement will not affect patient outcome. Data will be collected, stored, used and destroyed in accordance with the Data Protection Act and GDPR guidelines and will only be accessible by the research team.
Where is the study run from?
North East Ambulance Service NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2020 to April 2021 (updated 12/08/2020, previously: September 2020 (updated 06/07/2020, previously: June 2020))
Who is funding the study?
CRN North East and North Cumbria Investigator Initiated Commercially Funded Research Studies (IIT) PA allocation Award Scheme (UK)
Who is the main contact?
Karl Charlton
karl.charlton@neas.nhs.uk
Contact information
Scientific
Ambulance Headquarters
Bernicia House
Goldcrest Way
Newburn Riverside
Newcastle upon Tyne
NE15 8NY
United Kingdom
 ORCID ID |
0000-0002-9601-1083 |
|---|---|
| Phone | 0191 430 2294 |
| karl.charlton@neas.nhs.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | PaRamEDIc assessment of laCTate in out of hospital cardiac arrest: measuring the association with survival to hospital |
| Study acronym | PREDICT |
| Study objectives | Can a lactate measurement taken during an out of hospital cardiac arrest predict the patient's survival to hospital? |
| Ethics approval(s) | Approved 01/11/2019, Yorkshire and Humber – Bradford Leeds research ethics committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8018; nrescommittee.yorkandhumber-bradfordleeds@nhs.net), ref: 19/YH/0363, Confidentiality Advisory Group (CAG: 19/CAG/0201) |
| Health condition(s) or problem(s) studied | Out of hospital cardiac arrest |
| Intervention | During their cardiac arrest eligible participants will undergo a point of care blood lactate measurement. This is the only intervention participants will receive in addition to standard care. Some participants will not be transported to hospital and will be followed until the end of their episode of care. Some participants who are transported to hospital will not survive to discharge and these patients will be followed to 30 days, as will all survivors. Study paramedics will use a Nova Biomedical Stat Strip Xpress point of care lactate device to measure blood lactate from eligible participants. The blood lactate reading will be available to the paramedic in 13 seconds and will be recorded. The researchers will collect all the lactate readings and correlate this with data surrounding the cardiac arrest and patient outcome. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nova Biomedical Stat Strip Xpress |
| Primary outcome measure | Survival to hospital measured by the return of spontaneous circulation (ROSC) |
| Secondary outcome measures | 1. ROSC rate at any time 2. 30-day mortality |
| Overall study start date | 02/07/2019 |
| Completion date | 30/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 111 |
| Key inclusion criteria | 1. Aged 18 years and older 2. Eligible for resuscitation in accordance with current Resuscitation Council guidelines 3. Absence of do not attempt resuscitation (DNAR) order 4. In the catchment area of Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Key exclusion criteria | 1. Known or apparent pregnancy 2. Blunt or penetrating injury as primary cause of cardiac arrest 3. Absence of peripheral venous access |
| Date of first enrolment | 18/02/2020 |
| Date of final enrolment | 31/03/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Goldcrest Way
Newburn Riverside
Newcastle upon Tyne
NE15 8NY
United Kingdom
Sponsor information
Hospital/treatment centre
Bernicia House
Goldcrest Way
Newburn Riverside
Newcastle upon Tyne
NE15 8NY
England
United Kingdom
| Phone | +44 (0)191 430 2295 |
|---|---|
| michelle.jackson@neas.nhs.uk | |
| Website | https://www.neas.nhs.uk |
"ROR" |
https://ror.org/02mphet60 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Findings will be published in relevant medical journals, at conferences and to members of the public via the patient public outlets at North East Ambulance Service. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. Study data will be stored on a secure, password protected North East Ambulance Service Trust server and access will be strictly limited to the research team at North East Ambulance Service. All electronic will be anonymised. Paper documents in the form of consent forms will be stored securely in a locked filing cabinet in the research and development department at North East Ambulance Service NHS Foundation Trust and access to this will be strictly limited to the research team. Consent forms will be linked to electronic data by a linking document which will be stored separately and electronically on a North East Ambulance Service NHS Foundation Trust server, access to which will be strictly limited to the research team. All data will be stored in accordance with the Data Protection Act (2018) and the General Data Protection Regulation (GDPR) (2019). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 17/03/2022 | 17/03/2022 | No | No | |
| Protocol article | 02/03/2021 | 31/08/2022 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
31/08/2022: Publication reference added.
17/03/2022: The basic results of this trial have been uploaded as an additional file. The intention to publish date was changed from 30/08/2021 to 01/04/2022.
01/04/2021: Total final enrolment added.
12/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2020 to 31/03/2021.
2. The overall end date was changed from 30/09/2020 to 30/04/2021.
3. The intention to publish date was changed from 01/11/2020 to 30/08/2021.
4. The plain English summary was updated to reflect these changes.
06/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2020 to 31/08/2020.
2. The overall end date was changed from 30/06/2020 to 30/09/2020.
3. The plain English summary was updated to reflect these changes.
18/02/2020: Trial’s existence confirmed by Yorkshire and Humber – Bradford Leeds research ethics committee.
