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Peripheral Perfusion and Outcomes in ICU Patients With Sepsis

ConditionsSEPSISSeptic Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlexandra Elena Lazăr

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

The study population comprises adult patients admitted to the intensive care unit with sepsis or septic shock, defined according to Sepsis-3 criteria, with a Sequential Organ Failure Assessment (SOFA) score of ≥ 2 at the time of inclusion. Participants will be enrolled early after ICU admission and managed according to standard care and local treatment protocols. The study population consists of critically ill patients requiring invasive monitoring, enabling the assessment of peripheral perfusion using capillary refill time and paired arterial and venous blood gas analyses during the first 24 hours of ICU admission.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PERIPHERAL PERFUSION EVALUATION

    Other intervention

    This intervention consists of a predefined, multimodal peripheral perfusion assessment combining bedside clinical evaluation and blood gas analysis. Capillary refill time is measured at standardized time points, together with concurrent end-tidal carbon dioxide recording. Paired arterial and venous blood gas samples are obtained at the same time points to calculate the veno-arterial carbon dioxide difference and assess lactate levels. The intervention is limited to repeated physiological measurements during the first 24 hours of ICU admission and does not include any therapeutic intervention or protocol-driven change in clinical management

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: SEPTIC PATIENTS1 intervention

Trial outcomes

Primary outcomes

1

Change in Sequential Organ Failure Assessment (SOFA) score from inclusion (day 0) to day 3.

The SOFA score ranges from 0 to 24, with higher scores indicating greater organ dysfunction and worse clinical status. The change score is calculated as SOFA score at day 3 minus SOFA score at inclusion, with positive values indicating worsening organ dysfunction and negative values indicating improvement.

Time frame
From enrollemnt to day 3

Secondary outcomes

1

Ventilator-Free Days (0-7)

Ventilator-free survival days from day 0 to day 7, with death before day 7 assigned a value of 0.

Time frame
first 7 days
2

Vasopressor-Free Days (0-7)

Vasopressor-free survival days from day 0 to day 7 (death before day 7 scored as 0).

Time frame
first 7 days
3

Vital Status on Day 7

Survivor or non-survivor at day 7 after ICU admission.

Time frame
first 7 days
4

Vital Status on Day 28

Survivor or non-survivor at day 28 after ICU admission.

Time frame
first 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandra Elena Lazăr

Lead sponsor

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: