Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTrakya University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
28 days from ICU admissionSecondary outcomes
1
All-cause mortality in the intensive care unit
Proportion of patients who die from any cause during their ICU stay.
Time frame
From ICU admission to ICU discharge, up to 90 days2
All-cause in-hospital mortality
Proportion of patients who die from any cause before hospital discharge.
Time frame
From ICU admission to hospital discharge, up to 90 days3
All-cause mortality at 90 days
Proportion of patients who die from any cause within 90 days of ICU admission. Vital status of patients discharged before day 90 is ascertained through hospital records or telephone contact.
Time frame
90 days from ICU admission4
Vasopressor-free days at day 28
Number of days alive and free of any vasopressor support during the first 28 days after ICU admission. Patients who die within 28 days are assigned zero vasopressor-free days.
Time frame
28 days from ICU admissionSponsors and contacts
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Source ClinicalTrials.gov