Condition category
Circulatory System
Date applied
16/02/2020
Date assigned
18/02/2020
Last edited
18/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 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

Trial website

https://www.neas.nhs.uk/our-services/research-and-development/predict-study.aspx

Contact information

Type

Scientific

Primary contact

Mr Karl Charlton

ORCID ID

http://orcid.org/0000-0002-9601-1083

Contact details

Ambulance Headquarters
Bernicia House
Goldcrest Way
Newburn Riverside
Newcastle upon Tyne
NE15 8NY
United Kingdom
0191 430 2294
karl.charlton@neas.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

02072019, IRAS 271249

Study information

Scientific title

PaRamEDIc assessment of laCTate in out of hospital cardiac arrest: measuring the association with survival to hospital

Acronym

PREDICT

Study hypothesis

Can a lactate measurement taken during an out of hospital cardiac arrest predict the patient's survival to hospital?

Ethics approval

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)

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

02/07/2019

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Known or apparent pregnancy
2. Blunt or penetrating injury as primary cause of cardiac arrest
3. Absence of peripheral venous access

Recruitment start date

18/02/2020

Recruitment end date

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North East Ambulance Service NHS Foundation Trust Ambulance Headquarters
Bernicia House Goldcrest Way Newburn Riverside
Newcastle upon Tyne
NE15 8NY
United Kingdom

Sponsor information

Organisation

North East Ambulance Service NHS Foundation Trust

Sponsor details

Bernicia House
Goldcrest Way
Newburn Riverside
Newcastle upon Tyne
NE15 8NY
United Kingdom
+44 (0)191 430 2295
michelle.jackson@neas.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.neas.nhs.uk

Funders

Funder type

Government

Funder name

CRN North East and North Cumbria Investigator Initiated Commercially Funded Research Studies (IIT) PA allocation Award Scheme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
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).

Intention to publish date

01/11/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/02/2020: Trial’s existence confirmed by Yorkshire and Humber – Bradford Leeds research ethics committee.