Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit

NCT07740304 | Recruiting

• 1 other identifier: 2026-342
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

Sepsis is a life-threatening condition caused by the body's overwhelming response to infection, and it remains a leading cause of death in intensive care units. Even when standard treatment targets such as blood pressure are met, blood flow to the small vessels of the skin and other tissues may remain impaired. This "hidden" poor perfusion may not be detected by routine monitoring, yet it may be linked to worse outcomes. The perfusion index is a simple number obtained from the standard pulse oximeter already placed on a patient's finger. It reflects blood flow in the peripheral tissues, requires no additional procedure, and causes no discomfort. This prospective observational cohort study will examine whether the perfusion index, and especially how it changes over the first 24 hours in the intensive care unit, can help predict death within 28 days in adults with sepsis or septic shock. Capillary refill time and skin mottling score will be recorded as additional bedside measures of peripheral perfusion. No treatment will be changed for the purpose of this study, and no additional blood samples or invasive procedures will be performed. All care decisions remain with the treating team. Measurements will be taken at intensive care admission and at 6 and 24 hours. Participants will be followed for 28 days, with survival status also recorded at 90 days. The study will be conducted at two centers. A prediction model will be developed in the first center and then tested, without modification, in patients enrolled at the second center.

Conditions

Sepsis; Critical Illness

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 28 days

  Proportion of patients who die from any cause within 28 days of ICU admission. Vital status is ascertained through direct clinical follow-up during hospitalization and, for patients discharged before day 28, through hospital records or telephone contact.

  28 days from ICU admission

Secondary Outcomes (9)

• All-cause mortality in the intensive care unit

  From ICU admission to ICU discharge, up to 90 days

• All-cause in-hospital mortality

  From ICU admission to hospital discharge, up to 90 days

• All-cause mortality at 90 days

  90 days from ICU admission

• Vasopressor-free days at day 28

  28 days from ICU admission

• Duration of invasive mechanical ventilation

  From ICU admission to ICU discharge, up to 28 days

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (2)

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

Edirne, Merkez, 22130, Turkey (Türkiye)

RECRUITING

Uzunköprü State Hospital, Intensive Care Unit

Edirne, Uzunköprü, 22200, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• FARUK YILDIZ, MD

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensive Care Medicine Fellow, Division of Intensive Care Medicine

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): August 7, 2027
• Study Completion (Estimated): October 7, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

TU (2)