Peripheral Perfusion and Outcomes in ICU Patients With Sepsis (NCT07391098) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Peripheral Perfusion and Outcomes in ICU Patients With Sepsis
Romania80 participantsStarted 2026-02-02
Plain-language summary
People with sepsis who are treated in the intensive care unit (ICU) often have impaired blood flow to the skin and other tissues. These alterations in tissue perfusion may be associated with disease severity and clinical outcomes.
The aim of this study is to see whether simple signs of blood flow to the skin, such as capillary refill time and blood test measurements, are linked to outcomes in people with sepsis treated in the ICU.
Adults with sepsis who are admitted to the ICU will be invited to take part. Researchers will collect routine clinical data and blood test results during the first day of ICU treatment. No extra procedures or treatments will be performed as part of the study.
The results of this study may improve understanding of early signs of impaired circulation in sepsis and their relation with recovery and survival.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adults aged 18 years or older
* admission to the intensive care unit
* sepsis or septic shock, defined according to Sepsis-3 criteria
* SOFA score ≥ 2 at inclusion
* presence of an arterial line and a central venous catheter suitable for blood sampling
* possibility to perform peripheral perfusion assessment (CRT) at predefined time points
Exclusion Criteria:
* age under 18 years
* pregnancy
* expected ICU stay less than 24 hours
* limitations of therapy at ICU admission (e.g., DNR or comfort-only care)
* improper central venous catheter position (catheter tip not located in the superior vena cava)
* absence of arterial or central venous access required for paired blood gas sampling
* refusal of consent, when applicable according to local ethics requirements
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Sequential Organ Failure Assessment (SOFA) score from inclusion (day 0) to day 3.