Septic ShockSHOCKNCT07565649
Impact of Systematic Point-of-Care Ultrasound Implementation on Clinical Outcomes and Survival in Septic Shock: A Retrospective Single-Center Cohort Study
An observational study of Septic Shock and Sepsis, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2016to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Septic Shock, Sepsis
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (ICU admission) and 48 hours after ICU admission
Secondary outcomes (10)
28-day mortality
All-cause mortality within 28 days from ICU admission
Measured: Up to 28 days after ICU admission
60-day mortality
All-cause mortality within 60 days from ICU admission
Measured: Up to 60 days after ICU admission
90-day mortality
All-cause mortality within 90 days from ICU admission
Measured: Up to 90 days after ICU admission
Incidence of acute kidney injury
Occurrence of acute kidney injury during ICU stay
Measured: 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
Measured: 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
Measured: 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
Measured: From ICU admission to day 28
ICU length of stay
Length of stay in the intensive care unit
Measured: From ICU admission to day 28
Hospital length of stay
Total length of hospital stay
Measured: 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
Measured: Baseline (ICU admission), 24 hours, and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jan 2016
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvaro Casado Iglesias, MD, Principal investigator, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565649
- Sponsor's protocol ID
- POCUS-SHOCK
- Acronym
- SHOCK
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07565649
- Acronym / sponsor ID
- SHOCK / POCUS-SHOCK
- Conditions
- Septic Shock, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in SOFA score at 48 hours (Delta SOFA)
Time frame: 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.
10 secondary outcomes
28-day mortality
Time frame: Up to 28 days after ICU admission
60-day mortality
Time frame: Up to 60 days after ICU admission
90-day mortality
Time frame: Up to 90 days after ICU admission
Incidence of acute kidney injury
Time frame: From ICU admission to ICU discharge
Vasopressor-free days up to day 28
Time frame: From ICU admission to day 28
Mechanical ventilation-free days up to day 28
Time frame: From ICU admission to day 28
Renal replacement therapy-free days up to day 28
Time frame: From ICU admission to day 28
ICU length of stay
Time frame: From ICU admission to day 28
Hospital length of stay
Time frame: Through hospital discharge, an average of 28 days
Change in qSOFA score at 24 and 72 hours
Time frame: Baseline (ICU admission), 24 hours, and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvaro Casado Iglesias, MD principal investigator
Clinica Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Sepsis, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SOFA score at 48 hours (Delta SOFA) (time frame: Baseline (ICU admission) and 48 hours after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.