SEPSISPERFUSE-ICUNCT07391098
Peripheral Perfusion and Outcomes in ICU Patients With Sepsis
An observational study of SEPSIS and Septic Patients, run by Alexandra Elena Lazăr at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SEPSIS, Septic Patients
- What is being tested?
- PERIPHERAL PERFUSION EVALUATION
- How many people
- 80 participants
- Where
- 1 siteRomania
- Study dates
- 2 Feb 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Emergebcy Clinical County Hospital - Intensive Care Clinic
Târgu Mureş, Mureș County, 540136
Alexandra Elena Lazăr, 0737067900, alexandralazar7@gmail.com
About this study
Official title: Peripheral Perfusion and Outcomes in ICU Patients With Sepsis (PERFUSE-ICU)
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.
Read more
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.
Read the 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.
- Conditions
- SEPSIS, Septic Patients
- Being tested
- PERIPHERAL PERFUSION EVALUATION
- 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
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERIPHERAL PERFUSION EVALUATIONOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PERIPHERAL PERFUSION EVALUATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollemnt to day 3
Secondary outcomes (4)
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.
Measured: first 7 days
Vasopressor-Free Days (0-7)
Vasopressor-free survival days from day 0 to day 7 (death before day 7 scored as 0).
Measured: first 7 days
Vital Status on Day 7
Survivor or non-survivor at day 7 after ICU admission.
Measured: first 7 days
Vital Status on Day 28
Survivor or non-survivor at day 28 after ICU admission.
Measured: first 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start2 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SEPSISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra Elena Lazăr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexandra Elena Lazăr, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Investigators
- Alexandra Elena Lazăr, Principal investigator, George Emil Palade University of Medicine, Pharmacy, Science and Technology from Tirgu Mures, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391098
- Sponsor's protocol ID
- GEPaladeU
- Acronym
- PERFUSE-ICU
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Perfusion and Outcomes in ICU Patients With Sepsis (PERFUSE-ICU)
- ClinicalTrials.gov ID
- NCT07391098
- Acronym / sponsor ID
- PERFUSE-ICU / GEPaladeU
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandra Elena LazărUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEPTIC PATIENTS | – | Other: PERIPHERAL PERFUSION EVALUATIONThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERIPHERAL PERFUSION EVALUATIONThis 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 | Other | SEPTIC PATIENTS |
Primary outcome
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.
4 secondary outcomes
Ventilator-Free Days (0-7)
Time frame: first 7 days
Vasopressor-Free Days (0-7)
Time frame: first 7 days
Vital Status on Day 7
Time frame: first 7 days
Vital Status on Day 28
Time frame: first 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for SEPSIS
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Elena Lazăr principal investigator
George Emil Palade University of Medicine, Pharmacy, Science and Technology from Tirgu Mures, Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SEPSIS and Septic Patients, run by Alexandra Elena Lazăr at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Elena Lazăr, Consultant, Assoc prof (+40737067900, alexandralazar7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sequential Organ Failure Assessment (SOFA) score from inclusion (day 0) to day 3. (time frame: From enrollemnt to day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.