Peripheral Perfusion and Outcomes in ICU Patients With Sepsis (PERFUSE-ICU)

Alexandra Elena Lazăr

Status: Not yet enrolling

Conditions: Septic Patients; SEPSIS

Treatments: Other: PERIPHERAL PERFUSION EVALUATION

Study type: Observational

Funder types: Other

Identifiers

NCT07391098

GEPaladeU

Details and patient eligibility

About

People with sepsis who are treated in the intensive care unit (ICU) often have poor blood flow to the skin and other tissues. These changes in blood flow may be linked to how sick a person becomes and how well they recover.

The purpose 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 help doctors better understand early signs of poor circulation in sepsis and how these signs relate to recovery and survival.

Full 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. The relationship between these markers and outcomes in people with sepsis is not fully established.

This is a prospective observational cohort study conducted in adult ICU participants 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. Disease severity at baseline will be further characterized using the APACHE IV score.

Peripheral perfusion markers will be collected 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. Additional 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 seven and day twenty-eight.

No experimental treatments or protocol-driven changes to standard clinical management will be performed. 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• dults 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

Ability 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

Trial design

80 participants in 1 patient group

SEPTIC PATIENTS

Description:

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 performe

Treatment:

Other: PERIPHERAL PERFUSION EVALUATION