Prehospital mSOFA-Kit Decision Support for the Detection of Multiple Organ Failure
NCT07928674, Not applicable, Not yet recruiting, University of Valladolid
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prehospital mSOFA-Kit Decision Support for the Detection of Multiple Organ Failure | ClinicalTrials.gov |
| NCT number | NCT07928674 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 3,780 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Valladolid | ClinicalTrials.gov |
| Conditions | Multiple Organ Failure, Critical Illness | ClinicalTrials.gov |
| Interventions | mSOFA-Kit, Standard XABCDE assessment | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Composite adverse outcome at 2 days | 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. | ClinicalTrials.gov |
| Secondary | 28-day mortality | 28 days (+/- 2 days) | All-cause mortality within 28 days after prehospital care. | ClinicalTrials.gov |
| Secondary | 90-day mortality | 90 days (+/- 5 days) | All-cause mortality within 90 days after care | ClinicalTrials.gov |
| Secondary | ICU-free days at 28 days | 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). | ClinicalTrials.gov |
| Secondary | Mechanical ventilation-free days at 28 days | 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). | ClinicalTrials.gov |
| Secondary | Vasoactive drug-free days at 28 days | 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. | ClinicalTrials.gov |
| Secondary | Total hospital length of stay | 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. | ClinicalTrials.gov |
| Secondary | Appropriate activation of time-dependent codes | 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. | ClinicalTrials.gov |
| Secondary | Time to definitive intervention | 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). | ClinicalTrials.gov |
| Secondary | Rate of serious adverse events attributable to the device | 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%. | ClinicalTrials.gov |
| Secondary | Rate of device deficiencies | 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%. | ClinicalTrials.gov |
| Secondary | Serious incidents reported to EUDAMED | 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. | ClinicalTrials.gov |
| Secondary | Under-triage attributable to the score | Day 2 | Proportion of patients in the intervention arm with an mSOFA score \< 3 but with an adverse outcome at 2 days. | ClinicalTrials.gov |
| Secondary | Over-triage attributable to the score | 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. | ClinicalTrials.gov |
| Other | Effective use of the mSOFA-Kit | 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%. | ClinicalTrials.gov |
| Other | Interobserver variability of the mSOFA score | 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. | ClinicalTrials.gov |
| Other | Protocol adherence by USVA | 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%. | ClinicalTrials.gov |
| Other | Technology acceptance (TAM questionnaire) | 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. | ClinicalTrials.gov |
| Other | Rate of deferred consent (IC-C) | 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. | ClinicalTrials.gov |
| Other | Rate of data withdrawal after deferred consent | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)