Sepsis, Septic Shock
Conditions
Brief summary
This study aims to evaluate the clinical impact of the systematic implementation of point-of-care ultrasound (POCUS) in the management of patients with septic shock in the intensive care unit (ICU). Septic shock is associated with high morbidity and mortality, and its management requires timely and accurate hemodynamic assessment. Traditional monitoring methods have limitations in evaluating cardiac function, fluid responsiveness, and tissue perfusion. POCUS provides real-time, bedside, non-invasive assessment that may improve clinical decision-making. This is a retrospective, single-center cohort study comparing two time periods: a pre-implementation cohort (2016-2019) and a post-implementation cohort (2022-2025), excluding the COVID-19 pandemic period. The primary objective is to assess whether the implementation of POCUS is associated with an improvement in early organ dysfunction, measured as the change in SOFA score at 48 hours (delta SOFA). Secondary outcomes include mortality at 28, 60, and 90 days, incidence of acute kidney injury, duration of organ support therapies, and length of ICU and hospital stay.
Interventions
None listed
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Admission to the intensive care unit (ICU) with a clinical diagnosis or suspicion of septic shock * Microbiological confirmation of infection during clinical course * Availability of data required to calculate SOFA score at ICU admission and at 48 hours
Exclusion criteria
* ICU admissions during the period 2020-2021 * Readmissions related to the same episode of septic shock * Missing data required for SOFA score calculation * Patients with limitation of life-sustaining therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SOFA score at 48 hours (Delta SOFA) | Baseline (ICU admission) and 48 hours after ICU admission | Difference between the Sequential Organ Failure Assessment (SOFA) score at ICU admission and at 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | Up to 28 days after ICU admission | All-cause mortality within 28 days from ICU admission |
| 60-day mortality | Up to 60 days after ICU admission | All-cause mortality within 60 days from ICU admission |
| 90-day mortality | Up to 90 days after ICU admission | All-cause mortality within 90 days from ICU admission |
| Incidence of acute kidney injury | From ICU admission to ICU discharge | Occurrence of acute kidney injury during ICU stay |
| Vasopressor-free days up to day 28 | From ICU admission to day 28 | Number of days alive and free from vasopressor support within the first 28 days after ICU admission |
| Mechanical ventilation-free days up to day 28 | From ICU admission to day 28 | Number of days alive and free from mechanical ventilation within the first 28 days after ICU admission |
| Renal replacement therapy-free days up to day 28 | From ICU admission to day 28 | Number of days alive and free from renal replacement therapy within the first 28 days after ICU admission |
| ICU length of stay | From ICU admission to day 28 | Length of stay in the intensive care unit |
| Hospital length of stay | Through hospital discharge, an average of 28 days | Total length of hospital stay |
| Change in qSOFA score at 24 and 72 hours | Baseline (ICU admission), 24 hours, and 72 hours | Change in quick Sequential Organ Failure Assessment (qSOFA) score at 24 and 72 hours from ICU admission |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORAlvaro Casado Iglesias, MD
Clinica Universidad de Navarra
Outcome results
None listed