Pre-hospital identification of prognostic biomarkers in time-dependent diseases
| ISRCTN | ISRCTN48326533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48326533 |
| Secondary identifying numbers | GRS/1903/A/19 |
- Submission date
- 31/10/2019
- Registration date
- 04/11/2019
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Time-dependent diseases represent one of the most frequent causes of care by the Emergency Medical Services (EMS), one of the most frequent reasons for hospitalization and one of the main potential causes of early mortality. Health systems are making efforts to implement protocols for the management of this specific type of pathologies (infarction code, ICTUS, sepsis, etc). Being aware of the pathophysiological situation of the patient is essential to manage the situation, where early diagnosis is essential. The EMS perform standard advanced life support manoeuvres, with a wide technical capacity, but with very limited diagnostic means. For this reason, the general objective is to evaluate the prognostic capacity of the National Early Warning Score 2 scale, of prehospital analysis and of the joint level capnometry data (HITS score), to predict early mortality (before 48 hours) from the index event.
Who can participate?
Patients attended by Advanced Life Support (ALS) in the province of Valladolid
What does the study involve?
Patients undergo a structured and objective evaluation according to protocol and proceed to its stabilization. Respiratory rate, saturation, heart rate, blood pressure, temperate, coma scale score, and blood levels of lactic acid and glycemia values are measured. Once the patient is left in the Emergency Department they follow the normal course of treatment. 30 days after the index event (ALSU's attention at the scene) an analysis of the electronic clinical history of the participant is made to collect data on their hospital care and mortality data. At this moment, the observation will end. No interventions are performed on patients depending on the HITScore scale, but if the analytical or physiological data indicate urgent pathology, it will be acted on according to the EMS operating procedures. All participants receive the most appropriate treatment for their situation, regardless of the results of the study.
What are the possible benefits and risks of participating?
Through the use of this early warning scale, the clinical safety of patients is increased since the health system can perform a comprehensive follow-up of their situation. The scale also uses language easily understood by patients and professionals, which helps to facilitate the transmission of information. A delay in the timely identification of the critical pathology of the patient has a direct impact on the health system, with an increase in diagnostic procedures and surgical techniques, hospitalizations, stays in intensive care units or unexpected deaths. With the early identification of patients at high risk, it is intended to reduce morbidity and mortality. There are no known risks to participants taking part in this study.
Where is the study run from?
Health Emergency Management of Castilla y León (Spain), University Clinical Hospital of Valladolid (Spain), Rio Hortega University Hospital (Spain).
When is the study starting and how long is it expected to run for?
November 2019 to December 2023
Who is funding the study?
Regional Health Management of Castilla y León (SACYL) (Spain)
Who is the main contact?
Francisco Martín-Rodríguez
fmartin@saludcastillayleon.es
Contact information
Public
Medicine Faculty. Valladolid University
Av. Ramón y Cajal
7
Valladolid
47005
Spain
 ORCID ID |
0000-0002-1773-2860 |
|---|---|
| Phone | +34 (0)686452313 |
| fmartin@phet.es |
Study information
| Study design | Observational prospective cross-sectional cohort analytical non-intervention and multicenter study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Predictive value of biological, physiological and analytical biomarkers in the prehospital scope: observational, prospective, analytical, non-intervention and multicenter study |
| Study acronym | HITScore |
| Study hypothesis | Evaluate the prognostic capacity of different early warning scales (EWS, NEWS2, qSOFA, etc.), analytical biomarkers, and ETCO2 data, separately and at the joint level (HITS score) obtained at the prehospital level, to predict early mortality (before 48 hours) from the index event. |
| Ethics approval(s) | 1. Approved 07/10/2019, Comité de Ética de la Investigación con Medicamentos Área de Salud Valladolid Este (Hospital Clínico Valladolid, Facultad de Medicina, Farmacología, C/ Ramón y Cajal, 7 47005 Valladolid, España; Tel: 983 42 30 77; Email: alvarez@med.uva.es, jalvarezgo@saludcastillayleon.es), ref: PI-GR-19-1258 2. Approved 05/03/2019, CEIC Área de Salud de Valladolid Oeste (Hospital Universitario Río Hortega, 47012 Valladolid (Valladolid); Tel: 983 420 400; Email: rconvi@saludcastillayleon.es), ref: PI041-19 |
| Condition | Early mortality in all types of patients without evident signs of severity |
| Intervention | Patients and/or participants undergo a structured and objective evaluation according to protocol and proceed to its stabilization. The physiological variables are collected (respiratory rate, saturation, heart rate, blood pressure, temperate, coma scale score), and blood determination (capillary or venous if it is channeled via venous) of lactic acid and glycemia values is completed. Once the patient is left in the Emergency Department they will follow the normal course of treatment. 30 days after the index event (ALSU's attention at the scene) an analysis of the electronic clinical history of the participant is made to collect the data of their hospital care and mortality data. At this moment, the observation will end. |
| Intervention type | Mixed |
| Primary outcome measure | The following are evaluated at first attention at the scene of the incident: 1. Respiratory frequency, assessed using clinical observation at baseline 2. Oxygen saturation, assessed using a Physio LifePAK® 15 monitor at baseline 3. Non invasive ETCO2, assessed using a Physio LifePAK® 15 monitor at baseline 4. Heart rate, assessed using a Physio LifePAK® 15 monitor at baseline 5. Blood pressure, assessed using a Physio LifePAK® 15 monitor at baseline 6. Tympanic temperature assessed using a Braun model ThermoScan® PRO 6000 at baseline 7. Patient consciousness, assessed using the Glasgow Coma Scale at baseline 8. Use of oxygen (or not), evaluated using clinical observation at baseline 9. Analytical biomarkers: pH, pCO2, pO2, cHCO3-, BE (ecf), cSO2, Na +, K +, Ca ++, Cl-, TCO2, Agap, AGapK, Hct, Hb, BE (b), Glu, Lac, BUN, Urea and Crea, assessed using EPOC Siemens Healthcare at baseline 10. Electrocardiogram assessed using a Physio LifePAK® 15 monitor at baseline 11. Initial and route FiO2 assessed using a Physio LifePAK® 15 monitor at baseline 12. Prehospital diagnosis according to the Medical Priority Dispatch System incident code at baseline |
| Secondary outcome measures | 1. Early mortality at 48 hours 2. Presence of serious adverse events in prehospital scope at baseline 3. Presence of serious adverse events in hospital at 48 hours 4. Need for Intensive Care Unit at 30 days 5. Mortality from any cause at 30 days |
| Overall study start date | 15/11/2019 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 900 |
| Total final enrolment | 1114 |
| Participant inclusion criteria | 1. Treated by an ALSU 2. Aged over 18 years 3. Provide informed consent |
| Participant exclusion criteria | 1. Aged under 18 years 2. Cardiorespiratory arrest or exitus prior to arrival at the hospital 3. Pregnant 4. Psychiatric pathology 5. Diagnosis of end-stage disease (in treatment at a palliative care unit) 6. ALSU takes longer than 45 minutes to arrive 7. Evacuated by transport other than ambulance 8. Do not require transfer to the hospital |
| Recruitment start date | 01/12/2019 |
| Recruitment end date | 30/10/2021 |
Locations
Countries of recruitment
- Spain
Study participating centre
Valladolid
47006
Spain
Sponsor information
Government
Calle Antiguo Hospital Militar 2ª planta
Valladolid
47006
Spain
| Phone | +34 (0)983141061 |
|---|---|
| fmartin@saludcastillayleon.es | |
| Website | https://www.saludcastillayleon.es/ciudadanos/es/urgencias-emergencias/emergencias-sanitarias-castilla-leon |
"ROR" |
https://ror.org/02s8dab97 |
Funders
Funder type
Government
No information available
Government organisation / Local government
- Alternative name(s)
- University of Valladolid, UVA
- Location
- Spain
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | There is a study protocol and analysis plan that can be sent upon reasonable request. The research team will promote the dissemination of the results obtained in various scientific publications: 1. American Journal of Medicine 2. Critical Care Medicine 3. Emergencies 4. Intensive Care Medicine 5. Prehospital & Emergency Care 6. Resuscitation If external funding is obtained, communications could be sent to the main international emergency and emergencies forums |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from (F. Martín-Rodríguez, fmartin@saludcastillayleon.es). Statistical data will be available from the end of the data collection phase for 4 years. The data may be shared with researchers carrying out similar studies, provided that the exchange of information is mutual, by sending the anonymized data of patients. Patients will have signed informed consent for data sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/06/2021 | 06/07/2021 | Yes | No | |
| Results article | Prehospital point-of-care medication burden | 02/08/2024 | 23/04/2025 | Yes | No |
Editorial Notes
23/04/2025: Publication reference added.
13/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2021 to 31/12/2023.
2. The intention to publish date was changed from 30/12/2020 to 30/06/2024.
3. The plain English summary was updated to reflect these changes.
06/07/2021: Publication reference and total final enrolment added.
01/11/2019: Trial's existence confirmed by ethics committee.
