Prehospital recognition and antibiotics for 999 patients with severe sepsis
| ISRCTN | ISRCTN36856873 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36856873 |
| Secondary identifying numbers | 1 |
- Submission date
- 16/05/2017
- Registration date
- 24/05/2017
- Last edited
- 22/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Sepsis is a rare but serious complication of an infection. It kills between 36,000 and 64,000 people every year in the UK. Early diagnosis and treatment of sepsis has been shown to reduce the risk of death and improve health and well-being. Paramedics frequently come into contact with patients with sepsis, and are well placed to provide early diagnosis and treatment. This small study aims to find out whether paramedics can collect blood samples and give antibiotics to patients with severe sepsis. The aim is to find out whether it is feasible, safe and acceptable, so that a decision can be made about whether to proceed to a full study, which can confirm whether it is effective for patients and worthwhile for the NHS.
Who can participate?
Patients aged 18 and over, treated by participating paramedics and suspected of having severe 'Red Flag’ sepsis
What does the study involve?
Participating paramedics receive training to assist them to recognise severe sepsis. If severe 'Red Flag’ sepsis is suspected, paramedics randomly select a scratchcard, which informs them whether to provide enhanced care or usual care to the patient. All patients treated by the participating paramedics benefit from an enhanced level of assessment because of the additional training the paramedics receive. In addition to usual care, paramedics treating patients with enhanced care collect blood samples and give a first dose of intravenous antibiotics (into a vein) before the patient arrives at the hospital. Some of the patients are interviewed later and a focus group is held with paramedics to find out what they think about the intervention.
What are the possible benefits and risks of participating?
Participants may benefit from early antibiotic treatment. The antibiotic cefotaxime has already been confirmed to be safe and effective for the treatment of severe sepsis and is not under scrutiny in this study. Cefotaxime is widely used, generally well tolerated, and is the locally approved broad-spectrum antibiotic for the treatment of sepsis in Cardiff and Vale University Health Board. It is given to patients on admission to hospital as part of standard care. The more common side effects include diarrhoea, nausea, or abdominal discomfort, and are usually mild and temporary. Rarely observed side effects include allergic reactions, with the potential for anaphylaxis (a severe allergic reaction). Treatment of anaphylactic reactions is routine for paramedics, who have access to adrenaline and salbutamol for treating symptoms. Therefore the potential benefits of early use of cefotaxime by paramedics far outweigh the risks of an anaphylactic reaction. Participants who agree to follow up at 90 days may feel inconvenienced or experience a sense of intrusion when contacted. Before beginning the questionnaire process, participants are asked whether it is a convenient time for them and if not, an alternative time and date is arranged. Follow-up contact in the form of face-to-face meetings, postal correspondence and telephone calls is conducted in a friendly, courteous and timely manner.
Where is the study run from?
University Hospital Wales (UK)
When is the study starting and how long is it expected to run for?
March 2017 to February 2019
Who is funding the study?
Health and Care Research Wales (UK)
Who is the main contact?
Dr Jenna Bulger
j.k.bulger@swansea.ac.uk
Contact information
Public
ILS2, Singleton Park
Swansea
SA2 8PP
United Kingdom
 ORCID ID |
0000-0002-1280-4941 |
|---|---|
| Phone | +44 (0)179 251 3424 |
| j.k.bulger@swansea.ac.uk |
Study information
| Study design | Individually randomised feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | ISRCTN36856873_PIS_07Aug17_V2.1.pdf |
| Scientific title | Prehospital Recognition and Antibiotics for 999 patients with Severe sepsis (PHRASE): a feasibility study |
| Study acronym | PHRASE |
| Study hypothesis | That paramedics are able take blood cultures from and provide intravenous antibiotics to patients with severe sepsis in the prehospital environment before the patients arrives at the emergency department. |
| Ethics approval(s) | The Wales Research Ethics Committee 4, ref: 17-WA-0186 |
| Condition | Sepsis |
| Intervention | Sixty paramedics will be recruited to the study and will receive an enhanced level of training to assist them to recognise severe sepsis. If severe 'Red Flag’ sepsis is suspected, paramedics will select a scratchcard, which will inform them whether to provide enhanced care (intervention), or usual care (control). All patients managed by study paramedics will benefit from an enhanced level of assessment, because of the additional training the paramedics are provided in recognition of sepsis. In addition to usual care, paramedics treating patients in the intervention arm will collect prehospital blood cultures and give a first dose of intravenous antibiotics. 10 patients will be interviewed and a focus group will be held with paramedics to find out what they think about the intervention. Both groups will have follow up at 90 days, where they are sent a self reported quality of life questionnaire or it is recorded that the patient has died. |
| Intervention type | Other |
| Primary outcome measure | The feasibility of undertaking a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics providing IV antibiotics as early treatment for patients with severe sepsis. The trialists will assess whether or not to proceed to a full multi-site RCT based on the following progression criteria: 1. 60% of the 100 eligible paramedics agree to take part in the study 2. 70% of eligible patients consent to take part in the study 3. Follow-up data for potential primary outcomes can be collected for 70% or more of patients at 90 days 4. Mean patient satisfaction in intervention group is not less than 80% of patient satisfaction in the control group 5. Feasibility trial findings indicate that they remain in equipoise about the effectiveness of paramedic collection of blood cultures and antibiotic administration (i.e. that delivery of the intervention does not exceed a greater than 20-minute difference in on-scene times for patients compared to those in the control group) 6. Adverse event rate (e.g. allergic (anaphylactic) reactions to antibiotics) of less than 5% |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/03/2017 |
| Overall study end date | 28/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 118 |
| Participant inclusion criteria | 1. Adult patients 18 years of age and above 2. Attended by study paramedics 3. Identified as 'Red Flag’ sepsis 4. Admitted to participating hospital |
| Participant exclusion criteria | 1. Pregnancy (known or suspected) 2. Known history of allergy to antibiotics |
| Recruitment start date | 01/11/2017 |
| Recruitment end date | 31/05/2018 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Cardiff
CF14 4XN
United Kingdom
Sponsor information
Research organisation
Prehospital Emergency Research Unit
Lansdowne Hospital
Sanatorium Road
Cardiff
CF11 8PL
United Kingdom
"ROR" |
https://ror.org/017qpw206 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists plan to submit the protocol for publication to an appropriate journal after it has received ethics approval. Results of this feasibility trial will be available for publication in a peer-reviewed journal in approximately Spring 2019. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Swansea Trials Unit, ILS2, Singleton Campus, SA2 8PP. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2.1 | 07/08/2017 | 30/08/2017 | No | Yes |
| Protocol article | protocol | 12/03/2018 | Yes | No | |
| Results article | Results | 20/09/2021 | 22/09/2021 | Yes | No |
Additional files
- ISRCTN36856873_PIS_07Aug17_V2.1.pdf
- Uploaded 30/08/2017
Editorial Notes
22/09/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
16/11/2018: The recruitment end date was changed from 31/10/2018 to 31/05/2018.
23/03/2018: PubMed link added.
19/03/2018: Publication reference added.
30/08/2017: Ethics approval added. PIS file uploaded.
