SepsisNCT06727318
Comparison of Peripheral Perfusion Indicators and Lactate Levels
An observational study of Sepsis and Shock, Septic, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Shock, Septic, Hypotensive
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 18 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Septic shock patients in the intensive care unit
Who may be able to join
- 18 years of age or older
- Patients in septic shock
Who cannot join
- 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
Show all 9Show fewer
- Patients with chronic liver disease
- Black people
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Healty Sciences University Gulhane Training and Research Hospital
Ankara, KEÇİÖREN, 06010
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis, Shock, Septic, Hypotensive, Lactate, Lactic Acidosis
- Keywords
- SEPSİS, SEPTİC SHOCK, CAPİLLER REFİLL TİME, LACTATE İNCRASE, HYPOTENSİVE
- Medical subject headings
- Sepsis, Shock, Septic, Acidosis, Lactic, Toxemia
What is being measured
The primary outcome is the main question the study is designed to answer.
USE OF PERİFERAL PERFUSİON ASSESSMENT METHODS
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.
Measured: MAY 2024 SEPTEMBER 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 May 2024
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mete Erdemir, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727318
- Sponsor's protocol ID
- 2024/208
- Status last verified
- May 2024
- First submitted
- 15 Nov 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.
PubMed 2913385Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.
PubMed 21373821Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.
PubMed 25392034Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Capillary Refill Time and Serum Lactate Level in Predicting Disease Prognosis in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT06727318
- Acronym / sponsor ID
- 2024/208
- Conditions
- Sepsis, Shock, Septic, Hypotensive, Lactate, Lactic Acidosis
- Keywords
- SEPSİS, SEPTİC SHOCK, CAPİLLER REFİLL TİME, LACTATE İNCRASE, HYPOTENSİVE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 10 Dec 2024 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Septic shock patients in the intensive care unit
Key inclusion criteria (2 listed)
- 18 years of age or older
- Patients in septic shock
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 2913385Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.
- Results publication: PubMed 21373821Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.
- Results publication: PubMed 25392034Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.
- Results publication: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Shock, Septic, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 5 Dec 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USE OF PERİFERAL PERFUSİON ASSESSMENT METHODS (time frame: MAY 2024 SEPTEMBER 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06727318, which also lists 4 linked publications.
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 5 Dec 2025.