Impact of Systematic Point-of-Care Ultrasound Implementation on Clinical Outcomes and Survival in Septic Shock: A Retrospective Single-Center Cohort Study (SHOCK)
Impact of Systematic Implementation of Point-of-Care Ultrasound on Clinical Course and Survival in Patients With Septic Shock: A Retrospective Single-Center Cohort Study
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Navarre
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Pamplona, Navarre, Spanje, 31008
- Clinica Universidad de Navarra
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Pre-POCUS Cohort
Patients admitted to the ICU with septic shock between January 2016 and December 2019, before the systematic implementation of point-of-care ultrasound (POCUS).
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Post-POCUS Cohort
Patients admitted to the ICU with septic shock between January 2022 and December 2025, after the systematic implementation of point-of-care ultrasound (POCUS).
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in SOFA score at 48 hours (Delta SOFA)
Tijdsspanne: Baseline (ICU admission) and 48 hours after ICU admission
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Difference between the Sequential Organ Failure Assessment (SOFA) score at ICU admission and at 48 hours.
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Baseline (ICU admission) and 48 hours after ICU admission
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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28-day mortality
Tijdsspanne: Up to 28 days after ICU admission
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All-cause mortality within 28 days from ICU admission
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Up to 28 days after ICU admission
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60-day mortality
Tijdsspanne: Up to 60 days after ICU admission
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All-cause mortality within 60 days from ICU admission
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Up to 60 days after ICU admission
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90-day mortality
Tijdsspanne: Up to 90 days after ICU admission
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All-cause mortality within 90 days from ICU admission
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Up to 90 days after ICU admission
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Incidence of acute kidney injury
Tijdsspanne: From ICU admission to ICU discharge
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Occurrence of acute kidney injury during ICU stay
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From ICU admission to ICU discharge
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Vasopressor-free days up to day 28
Tijdsspanne: From ICU admission to day 28
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Number of days alive and free from vasopressor support within the first 28 days after ICU admission
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From ICU admission to day 28
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Mechanical ventilation-free days up to day 28
Tijdsspanne: From ICU admission to day 28
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Number of days alive and free from mechanical ventilation within the first 28 days after ICU admission
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From ICU admission to day 28
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Renal replacement therapy-free days up to day 28
Tijdsspanne: From ICU admission to day 28
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Number of days alive and free from renal replacement therapy within the first 28 days after ICU admission
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From ICU admission to day 28
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ICU length of stay
Tijdsspanne: From ICU admission to day 28
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Length of stay in the intensive care unit
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From ICU admission to day 28
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Hospital length of stay
Tijdsspanne: Through hospital discharge, an average of 28 days
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Total length of hospital stay
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Through hospital discharge, an average of 28 days
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Change in qSOFA score at 24 and 72 hours
Tijdsspanne: Baseline (ICU admission), 24 hours, and 72 hours
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Change in quick Sequential Organ Failure Assessment (qSOFA) score at 24 and 72 hours from ICU admission
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Baseline (ICU admission), 24 hours, and 72 hours
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Alvaro Casado Iglesias, MD, Clinica Universidad de Navarra
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- POCUS-SHOCK
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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