Peripheral Perfusion and Outcomes in ICU Patients With Sepsis

NCT07391098 | Not Yet Recruiting

• 1 other identifier: GEPaladeU
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

SEPSIS; Septic Patients

Keywords

Peripheral perfusion; Capillary refill time; Veno-arterial carbon dioxide difference; Sepsis outcomes; Tissue hypoperfusion; Intensive care unit; Veno-arterial carbon dioxide difference ΔCO₂ gap

Outcome Measures

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.

  From enrollemnt to day 3

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

Other: PERIPHERAL PERFUSION EVALUATION

Interventions

PERIPHERAL PERFUSION EVALUATION OTHER

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

SEPTIC PATIENTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• adults aged 18 years or older
• admission to the intensive care unit
• sepsis or septic shock, defined according to Sepsis-3 criteria
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandra Elena Lazăr: lead

Study Sites (1)

Emergebcy Clinical County Hospital - Intensive Care Clinic

Târgu Mureş, Mureș County, 540136, Romania

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra Elena Lazăr

  George Emil Palade University of Medicine, Pharmacy, Science and Technology from Tirgu Mures, Romania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Elena Lazăr, Consultant, Assoc prof

CONTACT

+40737067900; alexandralazar7@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate prof

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

RO (1)