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Bedside eye scans may reveal hidden blood flow problems in septic shock

NCT ID NCT04593212

Diagnosis Sponsor: Hospital da Luz, Portugal Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Sepsis and septic shock cause widespread inflammation and organ failure, and problems with the smallest blood vessels may drive worse outcomes. Researchers are testing whether a non-invasive eye imaging technique called optical coherence tomography angiography (OCTA) can detect these microcirculatory changes at the bedside. The study compares 165 septic shock patients with 30 healthy controls and follows patients for 90 days to see if eye findings predict organ failure or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
optical coherence tomography angiography (OCTA), a non-invasive eye imaging test
What this could lead to
If it works, doctors could use a quick eye scan at the bedside to spot hidden circulation problems in septic shock and better predict which patients are at highest risk.
What could go wrong
This is a small observational study, so it cannot prove that eye changes cause worse outcomes or that acting on them saves lives. The findings may not apply to all septic shock patients, and the imaging can be limited by eye conditions or poor image quality.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

30 people

The number who actually took part.

Started

Feb 2023

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Source population: 1. Cross-sectional case-control study: we intend to enrol 30 septic shock patients and 30 healthy controls. 2. Prospective cohort study: we intend to enrol 165 septic shock patients (the first 30 patients will be the same from the cross-sectional case-control study). The enrolment will take place from patients admitted to the Intensive Care Medicine Department of Hospital da Luz Lisboa, from February 2021 to February 2022. The healthy controls will be enrolled from our hospital staff.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥ 18 years-old * septic shock diagnosis (defined by the presence of sepsis according to Sepsis-3 definition plus a SOFA score ≥ 3 points at cardiovascular system despite adequate volume resuscitation) less than 24 hours before the first OCTA assessment Exclusion Criteria: * Inability or willingness to provide informed consent from the patient or next of kin * Shock due to any other cause without septic shock * Bilateral eye absence * Previously known retinopathy * Previous retinal surgery or photocoagulation * Pregnant women * Participants with psychiatry disorders

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Conditions

The condition(s) this trial relates to.

toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Septic shock

Contacts and locations

Locations

  • Hospital da Luz Lisboa

    Lisbon, Lisbon District, 1500-060, Portugal

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