NCT07740304 Peripheral Perfusion Index Trajectory to Predict 28-Day Mortality in Patients With Sepsis in the Intensive Care Unit
| NCT ID | NCT07740304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Trakya University |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-07-06 |
| Primary Completion | 2027-08-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2026-07-06 with a primary completion date of 2027-08-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
FARUK YILDIZ, MD
PRINCIPAL INVESTIGATOR
Trakya University
Frequently Asked Questions
Who can join the NCT07740304 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07740304 currently recruiting?
Yes, NCT07740304 is actively recruiting participants. Visit ClinicalTrials.gov or contact Trakya University to inquire about joining.
Where is the NCT07740304 trial being conducted?
This trial is being conducted at Edirne, Turkey (Türkiye), Edirne, Turkey (Türkiye).
Who is sponsoring the NCT07740304 clinical trial?
NCT07740304 is sponsored by Trakya University. The principal investigator is FARUK YILDIZ, MD at Trakya University. The trial plans to enroll 400 participants.