A randomised controlled trial of infusion protocols in adult pre-hospital care

ISRCTN	ISRCTN23500242
DOI	https://doi.org/10.1186/ISRCTN23500242
Secondary identifying numbers	HTA 93/23/19

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 07/04/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Nicholl
Scientific

School of Health and Related Research
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Phone	+44 (0)114 222 5201/2
Email	j.nicholl@sheffield.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	A randomised controlled trial of infusion protocols in adult pre-hospital care
Study objectives	The initiation of intravenous fluid replacement in injured patients at the accident scene is becoming a routine procedure. It has been assumed that early volume replacement in a bleeding patient will result in the patient arriving at hospital in a better haemodynamic state than if no fluids are given. However, some non-randomised studies of trauma patients and one quasi-randomised study of patients with severe bleeding injuries have begun to cast doubt on this assumption. In the UK most on-scene fluid therapy is given by ambulance-service paramedics acting in accordance with their protocols. We therefore conducted a pragmatic study to compare the effects of two different fluid protocols, one usually with fluid administration and one usually without, used by paramedics.
Ethics approval(s)	Approval from 16 local research ethics committees
Health condition(s) or problem(s) studied	Injury, occupational diseases, poisoning: Other injury, occupational diseases, poisoning
Intervention	With approval from 16 local research ethics committees, paramedics in two ambulance services were randomly allocated to one of two treatment protocols for the prehospital use of intravenous fluids in adult trauma patients. Paramedics who had been qualified for at least 1 year were randomised to an initial treatment protocol using a simple random-number generator. Approximately half way through the trial the paramedics were crossed over to the alternative protocol. Cluster randomised controlled. trial. Protocol A: intravenous fluids were administered at the incident scene to all adult trauma patients who under current procedures the paramedic would consider starting on intravenous fluids. Protocol B: fluids were withheld until arrival at hospital, unless the time to hospital was likely to be over 1 hour.
Intervention type	Other
Primary outcome measure	Death, complications, general health status (measured using the Short Form with 36 items (SF-36) questionnaire), processes of care and costs were measured up to 6 months post-incident.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/12/1995
Completion date	31/01/1998

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	1309
Total final enrolment	1309
Key inclusion criteria	Trauma patients aged 16 years or over who died or stayed in hospital for three or more nights and who were attended by a paramedic crew randomised to a treatment protocol were included in the study.
Key exclusion criteria	Patients with burns, poisoning, asphyxiation, minor uncomplicated skin or skeletal injuries, isolated fractured neck of femur, or who were pregnant were excluded.
Date of first enrolment	01/12/1995
Date of final enrolment	31/01/1998

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Health and Related Research

Sheffield
S1 4DA
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2000		Yes	No

Editorial Notes

07/04/2020: The final enrolment number has been added.