Identification of biomarkers of clinical-risk deterioration in prehospital care

Novel prehospital scores and outcomes based on biomarkers bedside: prospective, multicentric, ambulance-based, EMS-delivery, observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN49321933

Enrollment

5000

Registered

2021-02-25

Start date

2021-04-01

Completion date

Unknown

Last updated

2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early mortality in all types of patients without evident signs of severity Other

Interventions

Once the patient (or legal guardian) signs the informed consent form, he/she becomes part of the study. Vital signs are taken and a blood sample is taken from the venous line, which is inserted due to

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Evaluated by an EMS 2. Transfer to hospital in advanced or basic life support. 3. Aged over 18 years 4. Provide informed consent

Exclusion criteria

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. Do not require transfer to the hospital

Design outcomes

Primary

Measure	Time frame
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. Heart rate, assessed using a Physio LifePAK® 15 monitor at baseline 4. Blood pressure, assessed using a Physio LifePAK® 15 monitor at baseline 5. Tympanic temperature assessed using a Braun model ThermoScan® PRO 6000 at baseline 6. Patient consciousness, assessed using the Glasgow Coma Scale at baseline 7. Use of oxygen (or not), evaluated using clinical observation at baseline 8. 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, cardiac enzymes (proBNP, myoglobin, CK, D dimer and troponin) with Roche Cobas 232 and INR with Roche coagucheck 9. Electrocardiogram assessed using a Physio LifePAK® 15 monitor at baseline 10. Initial and route FiO2 assessed using a Physio LifePAK® 15 monitor at baseline The following are evaluated before arrival at the hospital: 1. Respiratory frequency, assessed using clinical observation at baseline 2. Oxygen saturation, assessed using a Physio LifePAK® 15 monitor at baseline 3. Heart rate, assessed using a Physio LifePAK® 15 monitor at baseline 4. Blood pressure, assessed using a Physio LifePAK® 15 monitor at baseline 5. Tympanic temperature assessed using a Braun model ThermoScan® PRO 6000 at baseline 6. Patient consciousness, assessed using the Glasgow Coma Scale at baseline 7. Use of oxygen (or not), evaluated using clinical observation at baseline 8. Prehospital diagnosis according to the Medical Priority Dispatch System incident code at baseline	—

Measure

Time frame

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. Heart rate, assessed using a Physio LifePAK® 15 monitor at baseline 4. Blood pressure, assessed using a Physio LifePAK® 15 monitor at baseline 5. Tympanic temperature assessed using a Braun model ThermoScan® PRO 6000 at baseline 6. Patient consciousness, assessed using the Glasgow Coma Scale at baseline 7. Use of oxygen (or not), evaluated using clinical observation at baseline 8. 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, cardiac enzymes (proBNP, myoglobin, CK, D dimer and troponin) with Roche Cobas 232 and INR with Roche coagucheck 9. Electrocardiogram assessed using a Physio LifePAK® 15 monitor at baseline 10. Initial and route FiO2 assessed using a Physio LifePAK® 15 monitor at baseline The following are evaluated before arrival at the hospital: 1. Respiratory frequency, assessed using clinical observation at baseline 2. Oxygen saturation, assessed using a Physio LifePAK® 15 monitor at baseline 3. Heart rate, assessed using a Physio LifePAK® 15 monitor at baseline 4. Blood pressure, assessed using a Physio LifePAK® 15 monitor at baseline 5. Tympanic temperature assessed using a Braun model ThermoScan® PRO 6000 at baseline 6. Patient consciousness, assessed using the Glasgow Coma Scale at baseline 7. Use of oxygen (or not), evaluated using clinical observation at baseline 8. Prehospital diagnosis according to the Medical Priority Dispatch System incident code at baseline

—

Secondary

Measure	Time frame
1. Mortality at 1, 2, 7, 14 and 28 days 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. Out-of-hospital mortality during a follow-up period of up to 1 year 6. Analytical data from the first blood draw at the hospital: leukocytes, hemoglobin, hematocrit, platelets, sodium, potassium, calcium, chloride, glucose, creatinine, bilirubin, CRP, PCT, troponin, D-dimer, proBNP and CK 7. Comorbidities 8. Triage level in the first contact in the emergency department	—

Measure

Time frame

1. Mortality at 1, 2, 7, 14 and 28 days 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. Out-of-hospital mortality during a follow-up period of up to 1 year 6. Analytical data from the first blood draw at the hospital: leukocytes, hemoglobin, hematocrit, platelets, sodium, potassium, calcium, chloride, glucose, creatinine, bilirubin, CRP, PCT, troponin, D-dimer, proBNP and CK 7. Comorbidities 8. Triage level in the first contact in the emergency department

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026