Peripheral Perfusion and Outcomes in ICU Patients With Sepsis (PERFUSE-ICU)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Alexandra Elena Lazăr
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in Sequential Organ Failure Assessment (SOFA) score from inclusion (day 0) to day 3.
Overview
Brief 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.
Detailed Description
Sepsis is a life-threatening condition caused by a dysregulated host response to infection and is associated with high morbidity and mortality in intensive care units (ICUs). Early detection of impaired tissue perfusion is essential for risk stratification and may help predict clinical outcomes.
Peripheral perfusion can be assessed using a combination of bedside clinical signs and physiological and biochemical markers. Capillary refill time (CRT) is a simple, non-invasive bedside measure of peripheral perfusion. In addition, respiratory and blood gas-derived variables, such as end-tidal carbon dioxide (ETCO₂) and the veno-arterial carbon dioxide difference (ΔCO₂), may reflect alterations in tissue blood flow and microcirculatory dysfunction. However, the relationship between these markers and clinical outcomes in patients with sepsis is not fully established.
This is a prospective observational cohort study conducted in adult ICU patients with sepsis or septic shock. Eligible participants will be enrolled after ICU admission. Sepsis will be defined according to Sepsis-3 criteria, with a Sequential Organ Failure Assessment (SOFA) score of 2 or higher at inclusion. Baseline disease severity will be further assessed using the Acute Physiology And Chronic Health Evaluation (APACHE) IV score.
Peripheral perfusion markers will be recorded at predefined time points: at inclusion (T0), six hours (T6), and twenty-four hours (T24). CRT and ETCO₂ will be measured at the bedside, using standardized methods. Arterial and venous blood gas samples will be obtained at the same time points to determine PaCO₂, PvCO₂, lactate levels, and the veno-arterial carbon dioxide difference (ΔCO₂). Blood sampling will be performed through existing arterial or venous catheters whenever possible.
Additional routinely collected clinical data will include hemodynamic variables, ventilatory parameters, vasopressor use, and organ support. Outcomes will include SOFA score on day three, ventilator-free days and vasopressor-free days within the first seven days, and vital status at day 7 and day 28.
No experimental treatments or protocol-driven changes to standard clinical management will be introduced. This study aims to evaluate the association between early peripheral perfusion markers-combining CRT, ETCO₂, and blood gas-derived variables-and short-term outcomes in adults with sepsis treated in the ICU.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SEPTIC PATIENTS
This cohort includes adult participants 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 or higher at inclusion.
Participants will receive standard ICU care according to local protocols. Peripheral perfusion will be assessed using capillary refill time and end-tidal carbon dioxide measurements at predefined time points (baseline, 6 hours, and 24 hours). In addition, paired arterial and venous blood gas samples will be collected at the same time points to evaluate markers of tissue perfusion, including lactate levels and the veno-arterial carbon dioxide difference.
No experimental treatments or protocol-driven changes to clinical management will be introduced.
Intervention: PERIPHERAL PERFUSION EVALUATION (Other)
Outcomes
Primary Outcomes
Change in Sequential Organ Failure Assessment (SOFA) score from inclusion (day 0) to day 3.
Time Frame: From enrollemnt 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.
Secondary Outcomes
- Ventilator-Free Days (0-7)(first 7 days)
- Vasopressor-Free Days (0-7)(first 7 days)
- Vital Status on Day 7(first 7 days)
- Vital Status on Day 28(first 28 days)
Investigators
Alexandra Elena Lazăr
Associate prof
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures