Comparison of Peripheral Perfusion Indicators and Lactate Levels

December 4, 2025 updated by: Mete Erdemir, Gulhane Training and Research Hospital

Comparison of Capillary Refill Time and Serum Lactate Level in Predicting Disease Prognosis in Patients With Septic Shock

In patients with septic shock undergoing intensive care unit monitoring, routine assessment of arterial and/or venous blood gas is conducted. During the period when arterial and/or venous blood gas is analyzed in this patient cohort, peripheral perfusion indicators will also be examined. Peripheral perfusion indicators will be appraised using capillary refill and mottling score. In patients experiencing septic shock, elevated lactate levels and progressive elevation of lactate levels during monitoring, prolonged capillary refill time exceeding 3 seconds, protracted capillary refill time, mottling development, and escalating mottling score are prognostic indicators of poor outcomes. The objective of this prospective study is to assess the correlation between capillary refill time and mottling score, concurrently evaluated, and serum lactate levels in arterial and/or venous blood gas.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Sepsis is defined as life-threatening organ dysfunction caused by dysregulated host response to infection(1). Patients with septic shock can be characterized by a clinical table of sepsis with a serum lactate level >2 mmol/L (18mg/dL) despite adequate fluid resuscitation and persistent hypotension requiring vasopressors to maintain a mean arterial pressure (MAP) ≥65 mm Hg (2). Shock is characterized by signs of tissue hypoperfusion, including increased serum lactate levels and abnormal peripheral perfusion (3). Mottling of the leg is a finding indicating impaired peripheral perfusion(4). Inadequate reduction of high lactate levels with treatment has been associated with an increased risk of death(5). Demographic data of all patients (age, gender, educational status, occupation), comorbidities, APACHE-II score, SOFA score, Charlson Comorbidity index, SAPS-II, MV support, service of transfer to intensive care unit, day of septic shock diagnosis; CRP, procalcitonin, albumin, fibrinogen, WBC, neutrophil count, lymphocyte, platelet count, INR, culture results, disseminated intravascular coagulation (DIC) score, capillary refill, mottling score, blood gas serum lactate level and base deficit, arterial pCO2 value, venous pCO2 value, arterio-venous PCO2 gradient difference, urine volume, vasopressor dose, mean arterial pressure and other vital signs will be noted. Arterial and/or venous blood gases measured every 6 hours from the time of diagnosis and concurrent peripheral perfusion findings (capillary refill time, mottling score) will be noted in the first 24 hours. Capillary refill time was planned to be measured by applying strong pressure to the ventral surface of the distal phalanx of the right index finger with a glass microscope slide. The pressure was planned to continue for 10 seconds after the nail bed turned white. The time to return to normal skin color will be recorded with a chronometer and a refill time longer than 3 seconds will be considered abnormal. In addition, mottling score will be examined as another peripheral perfusion examination outcome. Mottling score is as described below; If there is no mottling, the score will be considered as 0. If there is a coin-sized mottled discoloration in the knee, the score will be evaluated as 1, if the discoloration continues to the upper part of the kneecap, the score will be evaluated as 2, if it reaches to the middle of the thigh, the score will be evaluated as 3, if it reaches to the groin, the score will be evaluated as 4, and if the discoloration exceeds the groin area, the score will be evaluated as 5. Thus, blood gas and peripheral perfusion findings will be noted every 6 hours in the first 24 hours after the patients who are followed up in the intensive care unit with a diagnosis of septic shock and who meet the inclusion criteria are included in the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • KEÇİÖREN
      • Ankara, KEÇİÖREN, Turkey (Türkiye), 06010
        • Healty Sciences University Gulhane Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Septic shock patients in the intensive care unit

Description

Inclusion Criteria:

  • 18 years of age or older
  • Patients in septic shock

Exclusion Criteria:

  • Patients who did not give consent for participation in the study
  • Patients under 18 years of age
  • Patients with aortic pathology
  • Patients with arrhythmias (arrhythmias affecting cardiac index)
  • Patients with peripheral arterial disease (Buerger's disease, etc.)
  • Patients with a diagnosis of Raynaud's disease
  • Patients with chronic liver disease
  • Black people
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
USE OF PERİFERAL PERFUSİON ASSESSMENT METHODS
Time Frame: MAY 2024 SEPTEMBER 2025
Arterial and/or venous blood gases measured every 6 hours from the time of diagnosis and concurrent peripheral perfusion findings (capillary refill time, mottling score) will be noted in the first 24 hours. Capillary refill time, mottling score, lactate level measurements will be evaluated separately for septic shock progression and 28-day mortality. Parameters that are significant for septic shock progression in univariate analysis will be evaluated with logistic regression analysis. Then, the correlation between the peripheral perfusion findings and lactate levels will be compared with correlation analysis.
MAY 2024 SEPTEMBER 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gulhane Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings