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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the intensive care unit with septic shock in a tertiary care hospital, identified through retrospective review of electronic medical records.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SOFA score at 48 hours (Delta SOFA)	Difference between the Sequential Organ Failure Assessment (SOFA) score at ICU admission and at 48 hours.	Baseline (ICU admission) and 48 hours after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	All-cause mortality within 28 days from ICU admission	Up to 28 days after ICU admission
60-day mortality	All-cause mortality within 60 days from ICU admission	Up to 60 days after ICU admission
90-day mortality	All-cause mortality within 90 days from ICU admission	Up to 90 days after ICU admission
Incidence of acute kidney injury	Occurrence of acute kidney injury during ICU stay	From ICU admission to ICU discharge
Vasopressor-free days up to day 28	Number of days alive and free from vasopressor support within the first 28 days after ICU admission	From ICU admission to day 28
Mechanical ventilation-free days up to day 28	Number of days alive and free from mechanical ventilation within the first 28 days after ICU admission	From ICU admission to day 28
Renal replacement therapy-free days up to day 28	Number of days alive and free from renal replacement therapy within the first 28 days after ICU admission	From ICU admission to day 28
ICU length of stay	Length of stay in the intensive care unit	From ICU admission to day 28
Hospital length of stay	Total length of hospital stay	Through hospital discharge, an average of 28 days
Change in qSOFA score at 24 and 72 hours	Change in quick Sequential Organ Failure Assessment (qSOFA) score at 24 and 72 hours from ICU admission	Baseline (ICU admission), 24 hours, and 72 hours

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: Principal Investigator: Alvaro Casado Iglesias, MD, Clinica Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic
• Other Study ID Numbers: POCUS-SHOCK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No