A randomised controlled trial of infusion protocols in adult pre-hospital care
| ISRCTN | ISRCTN23500242 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23500242 |
| Protocol serial number | HTA 93/23/19 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
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 |
|---|---|
| j.nicholl@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/01/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
School of Health and Related Research
Sheffield
S1 4DA
United Kingdom
S1 4DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
