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A hidden clue in the fingertips: could a pulse oximeter reading forecast sepsis outcomes?

NCT ID NCT07740304

Knowledge-focused Sponsor: Trakya University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This study asks whether a simple, non-invasive reading from a standard pulse oximeter—the perfusion index—can help predict survival in people with sepsis or septic shock. Sepsis can impair blood flow to small vessels even when blood pressure looks normal, and this 'hidden' poor perfusion may be linked to worse outcomes. Researchers will track how the perfusion index changes over the first 24 hours in the ICU and see if it can predict death within 28 days, alongside other bedside measures. The study involves 400 adults across two centers and requires no extra procedures or changes to care.

What this could mean

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

What this could lead to
If the perfusion index proves reliable, it could give doctors a simple, non-invasive tool to spot hidden poor blood flow and better predict outcomes in sepsis patients.
What could go wrong
This is an observational study, so it can't prove cause and effect. The findings may not apply to all sepsis patients, and the perfusion index might not add much beyond existing tools.

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

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

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

Consecutive adults admitted to adult intensive care units with sepsis or septic shock according to Sepsis-3 criteria at two participating centers in Türkiye. Patients are screened and enrolled within the first 6 hours of intensive care unit admission. No sampling or selection beyond the eligibility criteria is applied; all consecutive eligible patients are approached during the enrollment period. Patients are enrolled irrespective of the source of admission (emergency department, hospital ward, operating room, or transfer from another facility), infection focus, or severity of illness at presentation.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age 18 years or older * Diagnosis of sepsis or septic shock according to Sepsis-3 criteria (suspected or confirmed infection with an acute increase in SOFA score of 2 points or more) * Enrollment possible within the first 6 hours of intensive care unit admission * Written informed consent obtained from the patient or, when the patient lacks decision-making capacity, from a legal representative, in accordance with the approved consent procedure Exclusion Criteria: * Conditions precluding valid peripheral perfusion measurement at both measurement sites, including severe peripheral arterial disease, limb ischemia or amputation, extensive edema or burns, or local trauma at the measurement site * Intensive care unit stay of 24 hours or longer at another facility prior to admission * Decision to withdraw or limit life-sustaining treatment planned within the first 24 hours * Pregnancy * Severe Raynaud phenomenon or vasospastic disease of the extremities * Persistent tremor or agitation precluding standardized measurement * Concurrent enrollment in an interventional study

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Conditions

The condition(s) this trial relates to.

Critical Illness infectious disease with sepsis Sepsis

As listed by the trial registrant

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

Critical illness Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Trakya University Faculty of Medicine, Department of Internal Medicine, Division of Intensive Care Medicine

    RECRUITING

    Edirne, Merkez, 22130, Turkey (Türkiye)

  • Uzunköprü State Hospital, Intensive Care Unit

    NOT_YET_RECRUITING

    Edirne, Uzunköprü, 22200, Turkey (Türkiye)

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