An interventional study of mSOFA-Kit and Standard XABCDE assessment in Multiple Organ Failure and Critical Illness, sponsored by University of Valladolid. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Valladolid · Not applicable, Interventional, and Health services research
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:
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.
193 studies on the registry are indexed under Multiple Organ Failure; 47 are open to participants now.
This study's planned enrollment of 3,780 is above the median of 88 across 90 interventional studies indexed under Multiple Organ Failure.
Browse Multiple Organ Failure studies →University of Valladolid is the lead sponsor of 34 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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.
Composite adverse outcome at 2 days
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.
Time frame: 48 hours (+/- 6 hours) after hospital admission
28-day mortality
All-cause mortality within 28 days after prehospital care.
Time frame: 28 days (+/- 2 days)
90-day mortality
All-cause mortality within 90 days after care
Time frame: 90 days (+/- 5 days)
ICU-free days at 28 days
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).
Time frame: Day 28
Mechanical ventilation-free days at 28 days
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).
Time frame: Day 28
Vasoactive drug-free days at 28 days
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.
Time frame: Day 28
Total hospital length of stay
Number of days from prehospital care to hospital discharge or in-hospital death; days at all hospitals are added in case of transfer.
Time frame: From prehospital care (day 0) until hospital discharge or in-hospital death, whichever came first, assessed up to 28 days
Appropriate activation of time-dependent codes
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 frame: From USVA arrival at the patient (day 0) up to 1 hour after hospital arrival
Time to definitive intervention
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).
Time frame: Up to 24 hours after USVA arrival
Rate of serious adverse events attributable to the device
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%.
Time frame: From inclusion (day 0) up to 90 days for each participant
Rate of device deficiencies
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%.
Time frame: From first participant inclusion through study completion, up to 31 months
Serious incidents reported to EUDAMED
Number of serious incidents reported to the Spanish Agency of Medicines and Medical Devices (AEMPS) via EUDAMED in accordance with MDCG 2020-10/1.
Time frame: From first participant inclusion through study completion, up to 31 months
Under-triage attributable to the score
Proportion of patients in the intervention arm with an mSOFA score \< 3 but with an adverse outcome at 2 days.
Time frame: Day 2
Over-triage attributable to the score
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.
Time frame: Day 2
Effective use of the mSOFA-Kit
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%.
Time frame: Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
Interobserver variability of the mSOFA score
Cohen's kappa between two independent assessors on the mSOFA score calculated manually from the medical record. Target kappa \> 0.90.
Time frame: Day 0 (on-scene mSOFA assessment)
Protocol adherence by USVA
Proportion of eligible responses in the intervention arm in which the complete workflow (IC + assessment + recording) was performed as established. Target \>= 85%.
Time frame: Assessed quarterly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
Technology acceptance (TAM questionnaire)
Mean score (scale 1-7) on the Technology Acceptance Model questionnaire administered to USVA staff of the intervention arm. Target \>= 5.0.
Time frame: Months 3 and 12 of use
Rate of deferred consent (IC-C)
Proportion of patients included through deferred consent over the total number recruited.
Time frame: Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
Rate of data withdrawal after deferred consent
Proportion of patients included via IC-C who, after regaining capacity, request the withdrawal of their data.
Time frame: Assessed monthly from month 1 to month 18 of recruitment (up to month 30 if Phase 2 is activated)
Change in mSOFA score (Delta 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).
Time frame: 48 hours from the scene mSOFA
Occult Hypoperfusion Index (OHI)
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).
Time frame: Measured on scene; outcomes at 48 hours
mSOFA decision tree
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 frame: Measured on scene; 2-day mortality
Time to activation of the appropriate code (hypothesis H3)
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).
Time frame: From USVA arrival up to 1 hour after hospital arrival
On-scene and total prehospital time
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).
Time frame: Day 0, from emergency activation to hospital arrival
Effect by baseline risk
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).
Time frame: 48 hours (+/- 6 hours) after hospital admission
Safety of on-scene discharge
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).
Time frame: 48 hours and 28 days after day 0
Added value over clinical judgement
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).
Time frame: Measured on scene; outcome at 48 hours
Destination and pre-alert
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).
Time frame: From prehospital care to day 28
Hospital SOFA
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).
Time frame: 48 hours after hospital arrival
28-day readmission
Hospital readmission within 28 days of discharge. Population: ITT, patients discharged alive. Prespecified exploratory outcome EX11 (SAP v1.0, doi:10.5281/zenodo.23696842).
Time frame: 28 days
Learning curve
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).
Time frame: 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)
Suspected infection subgroup
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).
Time frame: 48 hours (+/- 6 hours) after hospital admission
Validation of mSOFA risk categories
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).
Time frame: 2 days after day 0
mSOFA and longer-term mortality
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).
Time frame: 28 and 90 days after day 0
POCT-hospital laboratory agreement
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).
Time frame: Day 0 (on-scene sample and first hospital laboratory sample after arrival)
Prehospital suspected infection
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).
Time frame: From prehospital care to hospital discharge (up to day 28)
Diagnostic concordance
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).
Time frame: From prehospital care to hospital discharge (up to day 28)
Analgesia
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).
Time frame: Day 0, from USVA arrival at the patient to hospital arrival
Mediation
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).
Time frame: 48 hours (+/- 6 hours) after hospital admission
Physiological phenotypes
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).
Time frame: 48 hours (+/- 6 hours) after hospital admission
Comorbidity
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).
Time frame: 48 hours (+/- 6 hours) after hospital admission
Emergency department triage
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).
Time frame: Day 0, at emergency department arrival
Cost-effectiveness
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).
Time frame: Trial data up to 90 days; lifetime horizon by decision-analytic model
Plan to share: Yes — De-identified individual participant data underlying the published results, together with the analysis scripts, will be deposited in Zenodo (with DOI) under restricted access, in accordance with the ISCIII open science policy. Access is granted only to researchers designated by the principal investigator for research related to prehospital assessment of organ failure and risk stratification, with prior authorization of the CEIm de las Areas de Salud de Valladolid, as stated in the approved participant information sheet. Data shared outside the European Economic Area will be anonymized. The Statistical Analysis Plan (version 1.0) is publicly available: doi:10.5281/zenodo.23696842.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: From publication of the primary results until the end of the data retention period (10 years after study completion).
Access criteria: Researchers designated by the principal investigator, for projects related to the study's line of research with high scientific quality, after prior authorization of the CEIm de las Areas de Salud de Valladolid and signature of a data use agreement.
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University of Valladolid