Pilot trial comparing different fluid amounts given in the earliest stages of treatment in children presenting to UK emergency departments with a severe infection
| ISRCTN | ISRCTN15244462 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15244462 |
| Secondary identifying numbers | 16SM3292 |
- Submission date
- 03/08/2016
- Registration date
- 11/08/2016
- Last edited
- 18/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Septic shock is a life-threatening condition in which the blood pressure drops to dangerously low levels because of a serious blood infection (sepsis). Children are now much more likely to survive a septic shock than ever before. This progress comes from a whole package of treatments including antibiotics, multiple rapid doses (boluses) of fluid (saline (salt water) solution) into a child’s veins (‘fluid bolus therapy’) and support for breathing and heart function. This study is looking at refining the fluid bolus therapy part of this package by exploring what the best amount of fluid to give in the earliest stages of treatment is. In order to explore this, the study will monitor children to find out if giving less fluid per bolus to children with symptoms of a septic shock is better than giving a higher amount of fluid, as currently recommended. The aim of this study is to conduct a small version of the study to find out how feasible the study methods are and to find out if it is possible to recruit enough children to take part.
Who can participate?
Children under 16 years of age who are showing signs of septic shock, their parents or legal guardians, and hospital research teams.
What does the study involve?
In the first part of this study, children are randomly allocated to one of two groups. Those in the first group receive the current recommended bolus (dose) fluid therapy, of 20 ml/kg (maximum 1000 ml per bolus) every 15 minutes for four hours, until the signs of shock have gone or there are signs of fluid overload (a condition where there is too much fluid in the blood). Those in the second group receive smaller boluses of 10 ml/kg (maximum 500 ml per bolus) according to the same schedule. The type of fluids and other treatments given are left up to the medical team to decide. For both groups, the amount of fluid given to the children is recorded. In the second part of the study, parents/legal guardians of children participating in the first part of the study complete a number of questionnaires and telephone interviews to find out their views on the study process. Three focus groups with the hospital research teams are also held to explore their experiences of the study processes and consenting parents/legal representatives to the first part of the study.
What are the possible benefits and risks of participating?
It is not known whether there will be any additional benefits involved with participating in this study, however this study will help to improve the future treatment of children with septic shock. There are no notable risks involved with taking part.
Where is the study run from?
Thirteen NHS children’s hospitals in England (UK)
When is the study starting and how long is it expected to run for?
December 2015 to April 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Dr David Inwald (scientific)
2. Ms Ruth Canter (public) (ruth.canter@icnarc.org)
Contact information
Scientific
Paediatric Intensive Care Unit
Queen Elizabeth The Queen Mother (QEQM) Wing
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
Public
ICNARC CTU
Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom
| Phone | +44 (0)207 269 9277 |
|---|---|
| ruth.canter@icnarc.org |
Study information
| Study design | Mixed methods: 1. Multicentre, pragmatic, open, pilot randomised controlled trial 2. Qualitative questionnaires, interviews and focus groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN15244462_PIS.pdf |
| Scientific title | External pilot study of the Fluids in Shock (FiSh) trial |
| Study acronym | FiSh Pilot Study |
| Study hypothesis | The aim of this study is to explore and test important key parameters needed to inform the design and ensure the successful conduct of the FiSh trial. |
| Ethics approval(s) | London - Stanmore Research Ethics Committee, 14/06/2016, ref: 16/LO/0854 |
| Condition | Sepsis/Septic shock |
| Intervention | Patients are randomised 1:1 using sealed opaque envelopes available at each site. Intervention: Restrictive bolus fluid resuscitation of 10 ml/kg (maximum 500 ml per bolus) Control: Current recommended bolus fluid resuscitation of 20 ml/kg (maximum 1000 ml per bolus) Fluids to be delivered every 15 minutes for four hours, until clinical signs of shock has resolved or there are signs of fluid overload. Type of fluid and all other treatments are at the discretion of the treating clinician. |
| Intervention type | Other |
| Primary outcome measure | Feasibility of the intervention processes is determined by the evaluation of all the secondary outcomes at the end of the study, including a recommendation, or not, to continue to a larger trial. |
| Secondary outcome measures | 1. Eligibility rate is measured using the proportion of eligible patients randomised, as recorded on the screening and enrolment log at baseline 2. Recruitment rate is measured using the number of patients randomised per site per month, as recorded on the enrolment log and study database at baseline 3. Proportion of parents/guardians refusing deferred consent is measured using data recorded on the enrolment log and study database at hospital discharge or end of study (dependent upon timing of approach) 4. Proportion of fluid boluses delivered at correct volume and time during the intervention period is measured using data recorded on patient medical notes and the study database between randomisation and four hours post-randomisation 5. Total volume of fluid received during the intervention period is measured using data recorded on patient medical notes and the study database between randomisation and four hours post-randomisation 6. Proportion of complete data for each outcome measure is measured using data recorded on patient medical notes, the study database and linkage with routine data sources between randomisation and 30 days post-randomisation 7. Time taken for data collection and entry is measured using data from feedback from site staff during focus groups at the end of the study 8. Proportion of required data able to be linked to routine sources is measured using routine sources specification at the end of the study 9. Adverse events are measured using data recorded on patient medical notes and the study database between randomisation and 30 days post-randomisation |
| Overall study start date | 01/12/2015 |
| Overall study end date | 30/04/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Child |
| Lower age limit | 37 Weeks |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 108 |
| Total final enrolment | 75 |
| Participant inclusion criteria | Pilot RCT: Children: 1. Age greater than or equal to 37 weeks (corrected gestational age) and less than 16 years 2. Clinical suspicion of infection 3. Clinical signs of shock after receipt of 20 ml/kg of bolus fluid 4. Recruitment and randomisation to take place while child is in an acute assessment area (e.g. emergency department, paediatric assessment unit (PAU)) Observational component: Parent/Guardian inclusion criteria (questionnaire component): Parent/Guardians who were approached for consent prior to hospital discharge Parent/Guardian inclusion criteria (telephone interview component): Parent/Guardians who were approached for consent Site research staff: Site research staff who are involved in screening, recruiting, randomising and consenting during the pilot RCT. |
| Participant exclusion criteria | Pilot RCT: Children: 1. Prior receipt of more than 20 ml/kg of bolus fluid 2. Conditions in which bolus fluid resuscitation should be curtailed (e.g. raised intracranial pressure, diabetic ketoacidosis, known/suspected myocarditis/cardiomyopathy) 3. Full active resuscitation not within current goals of care Observational component: Parent/Guardian exclusion criteria (questionnaire and telephone interview): Parents/Guardians who do not speak English. |
| Recruitment start date | 13/07/2016 |
| Recruitment end date | 31/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
W2 1NY
United Kingdom
London
WC1N 3JH
United Kingdom
Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom
Southampton
SO16 6YD
United Kingdom
London
SW10 9NH
United Kingdom
Watford
London
WD18 0HB
United Kingdom
London
N19 5NF
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Taunton
TA1 5DA
United Kingdom
Exeter
EX2 5DW
United Kingdom
Bath
BA1 3NG
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Salisbury
SP2 8BJ
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Compliance Office
5th Floor, Laboratory Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
| Phone | +44 (0)203 311 0212 |
|---|---|
| jrco@imperial.ac.uk | |
"ROR" |
https://ror.org/056ffv270 |
Funders
Funder type
Government
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
Results and Publications
| Intention to publish date | 30/04/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A comprehensive report recommending the continuation, or not, to the full FiSh trial will be submitted to the NIHR HTA programme for publication in Health Technology Assessment. The findings from both the feasibility and the external pilot study will be widely disseminated and published in appropriate, peer-reviewed, scientific journals and, if appropriate, relevant professional journals within one year of the overall study end date. Following initial presentation of the results to the collaborating sites, the results will be presented at national and international conferences/meetings. The results of the combined feasibility and pilot study will be disseminated to families (children and their parents/guardians) via the Clinical Studies Group for Children (Anaesthesia, Pain, Intensive Care and Cardiology), facilitated by clinical co-investigators who sit on the group, and via the Young Person’s Advisory Group. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results in Health Technology Assessment journal | 01/09/2018 | Yes | No | |
| Results article | results | 01/05/2019 | 24/01/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | For use in feasibility study interviews | 18/09/2023 | No | Yes | |
| Results article | Qualitative interview study results | 28/08/2017 | 18/09/2023 | Yes | No |
Additional files
- ISRCTN15244462_PIS.pdf
- For use in feasibility study interviews
Editorial Notes
18/09/2023: Publication reference and patient information sheet added.
24/01/2020: Publication reference and total final enrolment number added.
24/09/2018: Publication reference added.
09/08/2018: Publication reference added.
03/03/2017: internal review.
23/12/2016: The following changes have been made to the record:
1. Basingstoke and North Hampshire Hospital and Royal Hampshire County Hospital have been removed from the list of participating centres and Salisbury District Hospital has been added
2. The recruitment start date has been updated from 13/06/2016 to 13/07/2016
