Peripheral Perfusion Index trajectory to predict 28-day mortality in sepsis patients in the ICU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study will track the peripheral perfusion index, derived from standard pulse oximetry, over the first 24 hours of ICU stay in adults with sepsis or septic shock. It aims to determine if PI trajectory adds predictive value for 28-day mortality beyond existing severity scores like SOFA. Additional bedside measures such as capillary refill time and skin mottling score will be recorded. The study does not introduce a treatment, but seeks to improve risk stratification by capturing microcirculatory perfusion dynamics. Enrollment is within 6 hours of ICU admission, and participation requires informed consent.

Why it matters

Who can join: the full rules

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

Where it's running

• Trakya University Faculty of Medicine, Department of Internal Medicine, Division of Intensive Care Medicine
  Edirne, Merkez, Turkey (Türkiye) Recruiting
• Uzunköprü State Hospital, Intensive Care Unit
  Edirne, Uzunköprü, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Faruk Yildiz, Md — Trakya University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.