Prehospital mSOFA-Kit Decision Support for the Detection of Multiple Organ Failure
Multiple Organ Failure · Critical Illness
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 3780 Estimado
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Acerca de la investigación
The goal of this clinical trial is to learn whether the mSOFA-Kit, a decision support system that calculates the modified Sequential Organ Failure Assessment (mSOFA) score on scene, improves the outcomes of adults attended by Advanced Life Support Units (USVA) for a potentially critical condition.
The main question it aims to answer is: does systematic on-scene stratification of multiorgan risk with the mSOFA-Kit reduce the 2-day composite adverse outcome (all-cause mortality, in-hospital cardiac arrest, admission to a level 2 or 3 ICU, invasive mechanical ventilation or renal replacement therapy) compared with the standard XABCDE assessment?
Researchers will compare USVAs using the mSOFA-Kit with a visible score (intervention arm) with USVAs applying standard XABCDE care with a blinded mSOFA score (control arm). Ambulance units, not individual patients, are randomly assigned to each arm. In both arms, a small venous blood sample, obtained from the peripheral venous catheter already placed for clinical care, is analyzed on scene with a point-of-care analyzer.
Participants will:
- receive the usual prehospital care of their emergency service;
- have their on-scene data and their hospital outcomes recorded;
- be followed up to 90 days through medical records and death registries.
Leer la descripción completa
Background. Prehospital multiple organ failure (MOF) is associated with high early mortality. The mSOFA score assesses five organ systems (respiratory SpO2/FiO2, Glasgow Coma Scale, creatinine, mean arterial pressure and lactate; total 0-17 points). In the predecessor project DTS23/00010, the mSOFA predicted 2-day mortality with an AUC of 0.949 (95% CI 0.939-0.958) in 12,212 patients (Alonso et al., eClinicalMedicine 2025).
Device. The mSOFA-Kit is an integrated system whose core is the mSOFA-App, Software as a Medical Device (Class IIb, Rule 11 MDR) without its own CE marking (Category (a), Royal Decree 192/2023 and Article 62 MDR). In the clinical investigation, the mSOFA-App operates with the epoc NXS point-of-care analyzer (Siemens Healthineers) and with the vital signs monitor of each USVA, both CE-marked and already part of the units' equipment.
Design. Multicenter, controlled, parallel-group (1:1) cluster-randomized clinical trial (cluster = USVA), with outcome assessment blinded to arm (PROBE design). Randomization is computerized, stratified by annual care volume of the USVA and type of unit (ground mobile ICU vs. air ambulance helicopter), in random permuted blocks. Outcomes are adjudicated by a Clinical Events Committee blinded to arm. An independent Data Safety Monitoring Board oversees safety.
Setting. Phase 1 takes place in Castilla y Leon, in the network of the Gerencia de Emergencias Sanitarias de Castilla y Leon (22 Mobile Emergency Units and 10 air ambulance helicopters). Outcome data are collected observationally at the 14 receiving hospitals of the SACYL network. Expansion to other Spanish regions (Phase 2) is planned if recruitment criteria are met.
Informed consent. Three pathways according to the patient's capacity: prior consent of the competent patient (IC-A), consent of the legal representative (IC-B) or deferred consent after stabilization (IC-C), with double verification of capacity by two crew members. Clinical care always takes precedence over any study procedure.
Sample size. 3,600 patients in Phase 1 (3,780 to be recruited, allowing for 5% losses); 5,220 (5,481 to be recruited) if Phase 2 is activated. Alpha 0.05 (two-sided), power 80%, expected reduction of the composite outcome from 25% to 20%.
Analysis. Generalized linear mixed model (binomial, logit link) with a random effect for cluster, adjusted for prespecified covariates; intention-to-treat as the primary analysis. One interim analysis at 50% of Phase 1 recruitment (Haybittle-Peto efficacy boundary, conditional power futility rule).
Statistical Analysis Plan. The Statistical Analysis Plan (version 1.0), including 23 prespecified exploratory outcomes and the economic evaluation, was signed on October 27, 2026, before inclusion of the first participant, and is publicly available: doi:10.5281/zenodo.23696842.
¿Quién podría participar?
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Inclusion Criteria:
- Age 18 years or older at the time of the incident.
- Attended by an Advanced Life Support Unit (USVA) participating in the study during the recruitment period.
- Clinical condition with any of the following characteristics that triggers systematic assessment: suspected sepsis, stroke, acute coronary syndrome, severe trauma (estimated ISS \> 15), shock (any etiology), neurological deterioration (GCS \< 13), severe acute dyspnea, or significant hemodynamic alteration (HR \> 130 or \< 45 bpm, or SBP \< 90 mmHg).
- Possibility of obtaining at least one venous point-of-care blood determination (0.1 mL).
- Valid informed consent obtained according to the pathway defined in the protocol (prior consent from the competent patient, consent from the legal representative, or deferred consent from the patient after stabilization, as appropriate).
Exclusion Criteria:
- Patient in refractory cardiorespiratory arrest with a documented decision to limit life-sustaining treatment before the arrival of the USVA.
- Express refusal to participate by the patient or, where applicable, by their legally designated representative.
- Patient deprived of liberty or in a situation of special vulnerability that compromises the validity of the informed consent.
- Simultaneous participation in another clinical or device trial whose interaction compromises the mSOFA assessment (to be assessed by the site coordinator).
- Patient previously included in the study during the same care episode (only the first response is included).
- Pregnancy (known or evident).
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
mSOFA-Kit (visible score)
The USVA has the fully operational mSOFA-Kit. The mSOFA score, the risk category and the protocol-based recommendations are visible to the team and are used in clinical decision-making (triage, activation of codes, hospital pre-alert, final destination).
Device: mSOFA-Kit
Standard XABCDE care (blinded mSOFA score)
The USVA applies the standard XABCDE protocol of its emergency service. The same point-of-care blood test is performed and the care team has access to its results, which it interprets according to usual practice. The mSOFA score is neither calculated nor displayed on scene.
Other: Standard XABCDE assessment
mSOFA-Kit DEVICE
Decision support system whose core is the mSOFA-App (Software as a Medical Device, Class IIb). From a venous point-of-care blood test (epoc NXS analyzer) and the vital signs of the USVA monitor, it automatically calculates the mSOFA score (0-17), stratifies the patient into 5 risk levels and displays protocol-based recommendations; it also supports structured pre-alert to the receiving hospital.
Standard XABCDE assessment OTHER
Standard prehospital care protocol (eXsanguination, Airway, Breathing, Circulation, Disability, Exposure) of each emergency medical service, with the point-of-care blood test available to the professional but without calculation or display of the mSOFA score.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Composite adverse outcome at 2 days
Plazo: 48 hours (+/- 6 hours) after hospital admission
Occurrence of at least one of the following clinically adjudicated events during the first 48 hours after arrival at the receiving hospital: (a) all-cause mortality; (b) in-hospital cardiac arrest; (c) admission to a level 2 or 3 ICU; (d) need for invasive mechanical ventilation; (e) need for renal replacement therapy. Adjudicated by the Clinical Events Committee blinded to arm.
Medidas secundarias
28-day mortality
Plazo: 28 days (+/- 2 days)
All-cause mortality within 28 days after prehospital care.
90-day mortality
Plazo: 90 days (+/- 5 days)
All-cause mortality within 90 days after care
ICU-free days at 28 days
Plazo: Day 28
Number of days between day 0 and day 28 on which the patient is alive and not admitted to the ICU (0 if the patient dies during the period or remains in the ICU for the full 28 days).
Mechanical ventilation-free days at 28 days
Plazo: Day 28
Number of days between day 0 and day 28 on which the patient is alive and not receiving mechanical ventilation (invasive, or non-invasive sustained for more than 12 consecutive hours).
Vasoactive drug-free days at 28 days
Plazo: Day 28
Number of days between day 0 and day 28 on which the patient is alive and not receiving norepinephrine, dopamine, epinephrine or vasopressin by continuous intravenous infusion.
Total hospital length of stay
Plazo: From prehospital care (day 0) until hospital discharge or in-hospital death, whichever came first, assessed up to 28 days
Number of days from prehospital care to hospital discharge or in-hospital death; days at all hospitals are added in case of transfer.
Appropriate activation of time-dependent codes
Plazo: From USVA arrival at the patient (day 0) up to 1 hour after hospital arrival
Proportion of patients with the appropriate clinical code (sepsis, stroke, acute myocardial infarction, major trauma) activated within the time recommended by emergency medical service guidelines and scientific societies.
Time to definitive intervention
Plazo: Up to 24 hours after USVA arrival
Time (minutes) from arrival of the USVA at the patient to the first definitive intervention at the receiving hospital (start of targeted antibiotic therapy, thrombolysis, percutaneous coronary intervention, surgical damage control).
Rate of serious adverse events attributable to the device
Plazo: From inclusion (day 0) up to 90 days for each participant
Serious adverse events clinically attributable to the use of the mSOFA-Kit (categorized by the Clinical Events Committee) over the total number of patients in the intervention arm. Prespecified acceptance threshold: \< 0.5%.
Rate of device deficiencies
Plazo: From first participant inclusion through study completion, up to 31 months
Device deficiencies (point-of-care testing failure, loss of connectivity, software error, discrepancy with the manufacturer's specifications) over the total number of uses. Threshold: \< 3%.
Serious incidents reported to EUDAMED
Plazo: From first participant inclusion through study completion, up to 31 months
Number of serious incidents reported to the Spanish Agency of Medicines and Medical Devices (AEMPS) via EUDAMED in accordance with MDCG 2020-10/1.
Under-triage attributable to the score
Plazo: Day 2
Proportion of patients in the intervention arm with an mSOFA score \< 3 but with an adverse outcome at 2 days.
Over-triage attributable to the score
Plazo: Day 2
Proportion of patients in the intervention arm with an mSOFA score \>= 4 but without an adverse outcome at 2 days and without need for ICU resources.
Otras medidas
Effective use of the mSOFA-Kit
Plazo: Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
Proportion of eligible responses in the intervention arm in which the kit was used in full (score calculated + complete POCT + data transmitted to the eCRF). Target \>= 85%.
Interobserver variability of the mSOFA score
Plazo: Day 0 (on-scene mSOFA assessment)
Cohen's kappa between two independent assessors on the mSOFA score calculated manually from the medical record. Target kappa \> 0.90.
Protocol adherence by USVA
Plazo: Assessed quarterly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
Proportion of eligible responses in the intervention arm in which the complete workflow (IC + assessment + recording) was performed as established. Target \>= 85%.
Technology acceptance (TAM questionnaire)
Plazo: Months 3 and 12 of use
Mean score (scale 1-7) on the Technology Acceptance Model questionnaire administered to USVA staff of the intervention arm. Target \>= 5.0.
Rate of deferred consent (IC-C)
Plazo: Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
Proportion of patients included through deferred consent over the total number recruited.
Rate of data withdrawal after deferred consent
Plazo: Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
Proportion of patients included via IC-C who, after regaining capacity, request the withdrawal of their data.
Change in mSOFA score (Delta mSOFA)
Plazo: 48 hours from the scene mSOFA
Death or increase of \>= 2 points in the mSOFA within 48 h from the scene mSOFA, same scale, worst values within 48 h (lowest MAP including the value before vasoactive drugs) (SAP Appendix B). Population: ITT. Prespecified exploratory outcome EX1 (SAP v1.0, doi:10.5281/zenodo.23696842).
Occult Hypoperfusion Index (OHI)
Plazo: Measured on scene; outcomes at 48 hours
OHI = lactate x (16 - GCS), scene values; applied only if scene mSOFA \< 5; positive if \>= 3.38; formula, restriction and threshold exactly as published, without refitting (del Pozo Vegas et al., BMC Medicine, accepted 2026). Calculated in the database in both arms; not displayed in the application. Population: ITT, scene mSOFA \< 5. Prespecified exploratory outcome EX2 (SAP v1.0, doi:10.5281/zenodo.23696842).
mSOFA decision tree
Plazo: Measured on scene; 2-day mortality
Classification of each patient as predicted survivor or non-survivor with the published decision tree (López Ballesteros et al., QJM, accepted 2026), applied without refitting: lactate \< 4 mmol/L -\> GCS \>= 9.5: survivor; GCS \< 9.5 -\> creatinine \< 1 mg/dL: survivor, \>= 1: non-survivor. Lactate \>= 4 mmol/L -\> SpO2/FiO2 \< 445: non-survivor; \>= 445 -\> GCS \< 11.5: non-survivor; GCS \>= 11.5 -\> creatinine \< 1.44 mg/dL: survivor, \>= 1.44: non-survivor. Population: ITT. Prespecified exploratory outcome EX3 (SAP v1.0, doi:10.5281/zenodo.23696842).
Time to activation of the appropriate code (hypothesis H3)
Plazo: From USVA arrival up to 1 hour after hospital arrival
Minutes from USVA arrival at the patient to the first activation of the code corresponding to the hospital main diagnosis (sepsis, stroke, AMI, major trauma), on scene or in the emergency department. Population: ITT, patients with a hospital main diagnosis in these categories. Prespecified exploratory outcome EX4 (SAP v1.0, doi:10.5281/zenodo.23696842).
On-scene and total prehospital time
Plazo: Day 0, from emergency activation to hospital arrival
On-scene time (contact to transport start) and total prehospital time (activation to hospital arrival), in minutes. Population: ITT, transported patients. Prespecified exploratory outcome EX5 (SAP v1.0, doi:10.5281/zenodo.23696842).
Effect by baseline risk
Plazo: 48 hours (+/- 6 hours) after hospital admission
Arm effect on the primary outcome within each scene mSOFA risk level (1-5). Population: ITT. Prespecified exploratory outcome EX6 (SAP v1.0, doi:10.5281/zenodo.23696842).
Safety of on-scene discharge
Plazo: 48 hours and 28 days after day 0
Death and primary-outcome events within 48 h and death within 28 days among patients discharged on scene without transport, by arm. Population: ITT, patients discharged on scene without transport. Prespecified exploratory outcome EX7 (SAP v1.0, doi:10.5281/zenodo.23696842).
Added value over clinical judgement
Plazo: Measured on scene; outcome at 48 hours
Discrimination of the prior clinical judgement (patient considered critical) versus the mSOFA, and their combination, for the primary outcome; proportion of cases in which the mSOFA changed the decision (intervention arm). Population: ITT. Prespecified exploratory outcome EX8 (SAP v1.0, doi:10.5281/zenodo.23696842).
Destination and pre-alert
Plazo: From prehospital care to day 28
In patients with scene mSOFA \>= 5: transport to a hospital with ICU, hospital pre-alert, and secondary inter-hospital transfer, by arm. Population: ITT, scene mSOFA \>= 5. Prespecified exploratory outcome EX9 (SAP v1.0, doi:10.5281/zenodo.23696842).
Hospital SOFA
Plazo: 48 hours after hospital arrival
Worst SOFA score within 48 h of hospital arrival (Vincent et al., 1996), calculated from the worst values recorded (SAP Appendix B). Population: ITT, hospitalized patients. Prespecified exploratory outcome EX10 (SAP v1.0, doi:10.5281/zenodo.23696842).
28-day readmission
Plazo: 28 days
Hospital readmission within 28 days of discharge. Population: ITT, patients discharged alive. Prespecified exploratory outcome EX11 (SAP v1.0, doi:10.5281/zenodo.23696842).
Learning curve
Plazo: 48 hours (+/- 6 hours) after hospital admission, assessed by quarter from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
Arm effect on the primary outcome according to calendar period of recruitment (quarters) and cumulative number of patients previously included by the cluster. Population: ITT. Prespecified exploratory outcome EX12 (SAP v1.0, doi:10.5281/zenodo.23696842).
Suspected infection subgroup
Plazo: 48 hours (+/- 6 hours) after hospital admission
Arm effect on the primary outcome in patients with and without prehospital suspected infection. Population: ITT. Prespecified exploratory outcome EX13 (SAP v1.0, doi:10.5281/zenodo.23696842).
Validation of mSOFA risk categories
Plazo: 2 days after day 0
Observed 2-day mortality in each mSOFA risk level compared with the published values (0.1%, 2.5%, 16.1%, 45.3%, 76.4%; del Pozo Vegas et al., Eur J Intern Med 2026) and negative predictive value of mSOFA \<= 2. Population: control arm, in which the score was not displayed; overall population as sensitivity analysis. Prespecified exploratory outcome EX14 (SAP v1.0, doi:10.5281/zenodo.23696842).
mSOFA and longer-term mortality
Plazo: 28 and 90 days after day 0
Discrimination and calibration of the scene mSOFA for 28-day and 90-day mortality. Population: ITT. Prespecified exploratory outcome EX15 (SAP v1.0, doi:10.5281/zenodo.23696842).
POCT-hospital laboratory agreement
Plazo: Day 0 (on-scene sample and first hospital laboratory sample after arrival)
Agreement between the scene epoc values and the first hospital laboratory values of lactate, creatinine, potassium, sodium, glucose and hemoglobin. Population: patients with both values. Prespecified exploratory outcome EX16 (SAP v1.0, doi:10.5281/zenodo.23696842).
Prehospital suspected infection
Plazo: From prehospital care to hospital discharge (up to day 28)
Sensitivity, specificity and predictive values of the prehospital item "suspected infection" for hospital sepsis (Sepsis-3); clinical profile of sepsis not suspected prehospital. Population: hospitalized patients. Prespecified exploratory outcome EX17 (SAP v1.0, doi:10.5281/zenodo.23696842).
Diagnostic concordance
Plazo: From prehospital care to hospital discharge (up to day 28)
Agreement between the prehospital main diagnosis and the hospital main diagnosis (aggregated categories of Protocol section 6.6), by arm. Population: hospitalized patients. Prespecified exploratory outcome EX18 (SAP v1.0, doi:10.5281/zenodo.23696842).
Analgesia
Plazo: Day 0, from USVA arrival at the patient to hospital arrival
Proportion of patients with pain \>= 4 (VAS 0-10) receiving prehospital analgesia (morphine, fentanyl, meperidine, metamizole, paracetamol, dexketoprofen or ketamine; SAP Appendix B), by arm. Population: ITT, VAS \>= 4. Prespecified exploratory outcome EX19 (SAP v1.0, doi:10.5281/zenodo.23696842).
Mediation
Plazo: 48 hours (+/- 6 hours) after hospital admission
Proportion of the arm effect on the primary outcome mediated by appropriate code activation, hospital pre-alert and transport to a hospital with ICU. Population: ITT. Prespecified exploratory outcome EX20 (SAP v1.0, doi:10.5281/zenodo.23696842).
Physiological phenotypes
Plazo: 48 hours (+/- 6 hours) after hospital admission
Phenotypes identified by robust model-based clustering (TCLUST) of the scene variables, and arm effect within each phenotype. Population: ITT. Prespecified exploratory outcome EX21 (SAP v1.0, doi:10.5281/zenodo.23696842).
Comorbidity
Plazo: 48 hours (+/- 6 hours) after hospital admission
Arm effect on the primary outcome by age-adjusted Charlson Comorbidity Index (\< 5 vs. \>= 5). Population: ITT. Prespecified exploratory outcome EX22 (SAP v1.0, doi:10.5281/zenodo.23696842).
Emergency department triage
Plazo: Day 0, at emergency department arrival
Manchester triage level on hospital arrival, by arm and by scene mSOFA risk level. Population: transported patients. Prespecified exploratory outcome EX23 (SAP v1.0, doi:10.5281/zenodo.23696842).
Cost-effectiveness
Plazo: Trial data up to 90 days; lifetime horizon by decision-analytic model
Incremental cost-effectiveness ratio in euros per quality-adjusted life year (QALY) gained and per composite adverse outcome avoided at 2 days, National Health System perspective, willingness-to-pay threshold EUR 25,000/QALY; QALYs estimated from survival with Spanish EQ-5D-5L population norms; lifetime horizon with 3% discount. Prespecified economic evaluation (SAP v1.0, doi:10.5281/zenodo.23696842).
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1 centros
Gerencia de Emergencias Sanitarias de Castilla y LeónValladolid, Castille and León, SpainEstado desconocido
Equipo y fechas
- Patrocinador principal
- University of Valladolid
- Inicio del estudio
- 1 abr 2027 Estimado
- Finalización primaria
- 31 oct 2029 Estimado
- Finalización del estudio
- 31 dic 2029 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Design, Construction and Clinical Validation of the mSOFA-Kit: Integrated Device for the Detection of Prehospital Multiple Organ Failure. A Cluster-Randomized Clinical Trial
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026