Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07928674

Prehospital mSOFA-Kit Decision Support for the Detection of Multiple Organ Failure

Conditions: Multiple Organ Failure, Critical Illness

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 3780
Sponsor: University of Valladolid

Location: Gerencia de Emergencias Sanitarias de Castilla y León Valladolid Castille and León

Summary

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.

Eligibility Criteria

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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07928674). StuddyBuddy aggregates publicly available trial information.