Peripheral Perfusion and Outcomes in ICU Patients With Sepsis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое PERIPHERAL PERFUSION EVALUATION
  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 measure

Первичные конечные точки

• Change in Sequential Organ Failure Assessment (SOFA) score from inclusion (day 0) to day 3. [Срок оценки: From enrollemnt to day 3]

Вторичные конечные точки (4)

• Ventilator-Free Days (0-7) [Срок оценки: first 7 days]
• Vasopressor-Free Days (0-7) [Срок оценки: first 7 days]
• Vital Status on Day 7 [Срок оценки: first 7 days]
• Vital Status on Day 28 [Срок оценки: first 28 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Румыния · 1 центр

• Emergebcy Clinical County Hospital - Intensive Care Clinic — Târgu Mureş

Идентификаторы

NCT: NCT07391098 · GEPaladeU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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