Impact of Systematic Point-of-Care Ultrasound Implementation on Clinical Outcomes and Survival in Septic Shock: A Retrospective Single-Center Cohort Study

NCT07565649 | Completed

• 1 other identifier: POCUS-SHOCK
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 28-day mortality

  Up to 28 days after ICU admission

• 60-day mortality

  Up to 60 days after ICU admission

• 90-day mortality

  Up to 90 days after ICU admission

• Incidence of acute kidney injury

  From ICU admission to ICU discharge

• Vasopressor-free days up to day 28

  From ICU admission to day 28

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Alvaro Casado Iglesias, MD

  Clinica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 4, 2026
• Study Start: January 1, 2016
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

ES (1)