InfectionsLIT-sepsisNCT05968287
Can Measurement of Neutrophil-derived ROS Production be a Novel Biomarker of Sepsis?
An observational study of Infections and Sepsis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Neutrophils are indispensable for host defense and have an important roles in modulating the immune system in both the innate and adaptive immune response. Neutrophils operate using a number of different mechanisms including chemotaxis, phagocytosis, release of reactive oxygen species (ROS) and granular proteins, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Sepsis, Septic Shock
- What is being tested?
- The Leukocyte ImmunoTest™ (LIT™)
- How many people
- 276 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2022to 31 Jan 2023
- 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: The patient population is consisted of patients who were admitted to the ICU or inward due various infectious etiologies. The control population is consisted of outpatients or inpatients admitted to ICU or inward for noninfectious etiologies.
Who may be able to join
- Diagnosis or suspicion of various infectious disease with or without sepsis and admitted to the ICU or inpatient service due to this clinical diagnosis for patient group
- Patients followed in the inpatient service due to various non-infectious diseases and outpatients who were examined in outpatient clinics for control group
Who cannot join
- patient or control group under the age of 18 years
- Patients died within the 24 hours after hospital admission
- Patients who did not sign informed consent
- Refusal of legal representative to participate in the study in unconscious patients
- Patients with an absolute neutrophil count <500/mm3 on admission
- Control group describing any infective symptoms
- Control group with a chronic infectious disease under treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship of Neutrophil Functions With Sepsis and Septic Shock Using the Leukocyte ImmunoTest™ in Patients With Various Infectious Conditions
Neutrophils are indispensable for host defense and have an important roles in modulating the immune system in both the innate and adaptive immune response. Neutrophils operate using a number of different mechanisms including chemotaxis, phagocytosis, release of reactive oxygen species (ROS) and granular proteins, and the production and liberation of cytokines for this purpose. A controlled neutrophil response is required to combat infection; an dysregulated state of this response can cause sepsis, tissue damage, and organ failure. Sepsis and septic shock are the leading causes of death especially in intensive care units (ICU), and their mortality can be reduced with prompt diagnosis and appropriate treatment modality. From this point of view, many biomarkers have been evaluated for the diagnosis, prognosis, and treatment response of infection and sepsis. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for the clinician in detecting and monitoring changes related to infection status and to determine development of sepsis and positive effects of interventions.
Read the detailed description
Introduction:
Sepsis is defined as the dysregulated host response to infection leading to organ dysfunction. Both sepsis and septic shock are important health problems affecting millions of people, resulting in a serious mortality rate around the world every year. Delay in both diagnosis and initiation of appropriate treatment are the most important causes of sepsis-related mortality. On the other hand, overdiagnosis of sepsis and initiation of broad-spectrum antibiotic therapy inappropriately have some consequences such as increased hospital costs, antibiotic-related side effects, increased antibiotic resistance, and the development of resistant nosocomial infections. To make this precise distinction, a large number of biomarkers have been studied until today. The expected benefit of sepsis-related biomarkers is the detection of infection and sepsis, the potential to predict the course of sepsis, or treatment guidance. Although there are more than 150 biomarkers studied on this subject, there is not a single biomarker that meets these expectations in all aspects in clinical practice.
Neutrophils play a vital role in the development of the host response in sepsis. Neutrophils operate using a number of different mechanisms including chemotaxis, phagocytosis, release of reactive oxygen species (ROS) and granular proteins, and the production and liberation of cytokines for this purpose. A controlled neutrophil response is required to combat infections. Recently a functional assay that assesses the capacity of leukocytes (primarily neutrophils) to produce ROS in response to in vitro chemical stimulation has been demonstrated. The Leukocyte ImmunoTest™ (LIT™) specifically and rapidly (10 minutes) quantifies neutrophil ROS release using a small volume of blood obtainable from capillary, arterial or venous sources. As such the LIT score provides a physiologically relevant means for monitoring the cellular capacity of neutrophils to produce superoxide radicals in real time. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for the clinician in detecting and monitoring changes related to infection status and to determine development of sepsis and positive effects of interventions.
Method:
The study was conducted as a prospective observational study with ethical committee approval in a medical intensive care unit and inward belong to internal disease department of a university hospital. The patient population is consisted of patients who were admitted to the ICU or inward due various infectious etiologies. The control group is consisted of outpatients or inpatients admitted to ICU or inward for noninfectious etiologies. ROS production in response to PMA was performed on clinical samples and analysed within 30 minutes of collection. The LIT test was performed every day or every other day for patient group until death or discharge from units where the study is conducted. The LIT test was performed only once for outpatient group on day of outpatient control.
Measurements of ROS production by luminometer:
ROS production was measured on clinical samples taken for routine testing. Briefly, 10μl samples of freshly obtained blood (obtained by venepuncture) was added to 100 microlitres phosphate buffered saline (PBS) containing phorbol 12-myristate 13-acetate (PMA; Sigma) and luminol. The solution was incubated for 10 minutes at 37.5 °C. Chemiluminescence was quantified after 10 minutes using handheld luminometer (3M, Clean-Trace, NG3) in relative light units (RLU). LIT scores as a correlate of neutrophil function for each patient were plotted. Abnormally high (hyperproduction) ROS generation was associated with infection, sepsis or septic shock. This raises the possibility of LIT™ and LIT™/neutrophil-count ratio, (LIT/N), being used as a predictive clinical tool.
- Conditions
- Infections, Sepsis, Septic Shock
- Being tested
- The Leukocyte ImmunoTest™ (LIT™)
- Keywords
- cellular dysfunction of neutrophils, reactive oxygen species (ROS), sepsis, septic shock, infections, biomarker
- Medical subject headings
- Infections, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Leukocyte ImmunoTest™ (LIT™)Diagnostic test
The baseline LIT scores was performed for two parallel groups. The sequential LIT score was also performed for patients with various infection conditions with/without sepsis.
| Study group | Role | What they receive |
|---|---|---|
| patient group | patients admitted to hospital with various infection conditions with or without sepsis Receives: Diagnostic Test: The Leukocyte ImmunoTest™ (LIT™) | |
| control group | patients admitted to hospital with various non-infectious diseases and outpatients who admitted to the outpatient clinics Receives: Diagnostic Test: The Leukocyte ImmunoTest™ (LIT™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)
the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between patients with various infection conditions and control groups without infection.
Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with infection. LIT scores as relative light unit (RLU) can vary between 1-15000.
Measured: Patients' LIT scores in relative light units (RLU) within 24 hours following the day of hospitalization during the study period
the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)
the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between patients between sepsis and without sepsis
Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with sepsis and septic shock. LIT scores as relative light unit (RLU) can vary between 1-15000.
Measured: LIT score as as relative light unit (RLU) of the day of detecting of infection and sepsis up to 8 months
Secondary outcomes (1)
the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)
the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between survivors and nonsurvivors within the septic patients.
Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with infection, sepsis and septic shock. LIT scores as relative light unit (RLU) can vary between 1-15000. The relationship of high scores of the LIT as relative light unit (RLU) with mortality will be evaluated.
Measured: the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) of the patients with sepsis on every day or every other day up to death or discharge from the hospital through the study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start28 Jun 2022
- Primary completion27 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Seroxo Ltd
- Responsible party
- Principal investigator, Nazlıhan Boyacı Dündar, Gazi University
- Investigators
- Nazlıhan Boyacı Dündar, assist.prof., Principal investigator, principle investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968287
- Sponsor's protocol ID
- GaziUtipNBDundar002
- Acronym
- LIT-sepsis
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mortaz E, Alipoor SD, Adcock IM, Mumby S, Koenderman L. Update on Neutrophil Function in Severe Inflammation. Front Immunol. 2018 Oct 2;9:2171. doi: 10.3389/fimmu.2018.02171. eCollection 2018.
PubMed 30356867Selders GS, Fetz AE, Radic MZ, Bowlin GL. An overview of the role of neutrophils in innate immunity, inflammation and host-biomaterial integration. Regen Biomater. 2017 Feb;4(1):55-68. doi: 10.1093/rb/rbw041.
PubMed 28149530Hellebrekers P, Vrisekoop N, Koenderman L. Neutrophil phenotypes in health and disease. Eur J Clin Invest. 2018 Nov;48 Suppl 2(Suppl Suppl 2):e12943. doi: 10.1111/eci.12943. Epub 2018 May 25.
PubMed 29682724Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330.
PubMed 24717459Pierrakos C, Velissaris D, Bisdorff M, Marshall JC, Vincent JL. Biomarkers of sepsis: time for a reappraisal. Crit Care. 2020 Jun 5;24(1):287. doi: 10.1186/s13054-020-02993-5.
PubMed 32503670Fleischmann-Struzek C, Mellhammar L, Rose N, Cassini A, Rudd KE, Schlattmann P, Allegranzi B, Reinhart K. Incidence and mortality of hospital- and ICU-treated sepsis: results from an updated and expanded systematic review and meta-analysis. Intensive Care Med. 2020 Aug;46(8):1552-1562. doi: 10.1007/s00134-020-06151-x. Epub 2020 Jun 22.
PubMed 32572531Rhee C, Chiotos K, Cosgrove SE, Heil EL, Kadri SS, Kalil AC, Gilbert DN, Masur H, Septimus EJ, Sweeney DA, Strich JR, Winslow DL, Klompas M. Infectious Diseases Society of America Position Paper: Recommended Revisions to the National Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Sepsis Quality Measure. Clin Infect Dis. 2021 Feb 16;72(4):541-552. doi: 10.1093/cid/ciaa059.
PubMed 32374861Biomarkers Definitions Working Group.. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001 Mar;69(3):89-95. doi: 10.1067/mcp.2001.113989. No abstract available.
PubMed 11240971Veenith T, Martin H, Le Breuilly M, Whitehouse T, Gao-Smith F, Duggal N, Lord JM, Mian R, Sarphie D, Moss P. High generation of reactive oxygen species from neutrophils in patients with severe COVID-19. Sci Rep. 2022 Jun 21;12(1):10484. doi: 10.1038/s41598-022-13825-7.
PubMed 35729319Singer 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship of Neutrophil Functions With Sepsis and Septic Shock Using the Leukocyte ImmunoTest™ in Patients With Various Infectious Conditions
- ClinicalTrials.gov ID
- NCT05968287
- Acronym / sponsor ID
- LIT-sepsis / GaziUtipNBDundar002
- Conditions
- Infections, Sepsis, Septic Shock
- Keywords
- cellular dysfunction of neutrophils, reactive oxygen species (ROS), sepsis, septic shock, infections, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Seroxo Ltd
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 1 Aug 2023 (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.
Neutrophils are indispensable for host defense and have an important roles in modulating the immune system in both the innate and adaptive immune response. Neutrophils operate using a number of different mechanisms including chemotaxis, phagocytosis, release of reactive oxygen species (ROS) and granular proteins, and the production and liberation of cytokines for this purpose. A controlled neutrophil response is required to combat infection; an dysregulated state of this response can cause sepsis, tissue damage, and organ failure. Sepsis and septic shock are the leading causes of death especially in intensive care units (ICU), and their mortality can be reduced with prompt diagnosis and appropriate treatment modality. From this point of view, many biomarkers have been evaluated for the diagnosis, prognosis, and treatment response of infection and sepsis. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for the clinician in detecting and monitoring changes related to infection status and to determine development of sepsis and positive effects of interventions.
Detailed description
Introduction:
Sepsis is defined as the dysregulated host response to infection leading to organ dysfunction. Both sepsis and septic shock are important health problems affecting millions of people, resulting in a serious mortality rate around the world every year. Delay in both diagnosis and initiation of appropriate treatment are the most important causes of sepsis-related mortality. On the other hand, overdiagnosis of sepsis and initiation of broad-spectrum antibiotic therapy inappropriately have some consequences such as increased hospital costs, antibiotic-related side effects, increased antibiotic resistance, and the development of resistant nosocomial infections. To make this precise distinction, a large number of biomarkers have been studied until today. The expected benefit of sepsis-related biomarkers is the detection of infection and sepsis, the potential to predict the course of sepsis, or treatment guidance. Although there are more than 150 biomarkers studied on this subject, there is not a single biomarker that meets these expectations in all aspects in clinical practice.
Neutrophils play a vital role in the development of the host response in sepsis. Neutrophils operate using a number of different mechanisms including chemotaxis, phagocytosis, release of reactive oxygen species (ROS) and granular proteins, and the production and liberation of cytokines for this purpose. A controlled neutrophil response is required to combat infections. Recently a functional assay that assesses the capacity of leukocytes (primarily neutrophils) to produce ROS in response to in vitro chemical stimulation has been demonstrated. The Leukocyte ImmunoTest™ (LIT™) specifically and rapidly (10 minutes) quantifies neutrophil ROS release using a small volume of blood obtainable from capillary, arterial or venous sources. As such the LIT score provides a physiologically relevant means for monitoring the cellular capacity of neutrophils to produce superoxide radicals in real time. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for the clinician in detecting and monitoring changes related to infection status and to determine development of sepsis and positive effects of interventions.
Method:
The study was conducted as a prospective observational study with ethical committee approval in a medical intensive care unit and inward belong to internal disease department of a university hospital. The patient population is consisted of patients who were admitted to the ICU or inward due various infectious etiologies. The control group is consisted of outpatients or inpatients admitted to ICU or inward for noninfectious etiologies. ROS production in response to PMA was performed on clinical samples and analysed within 30 minutes of collection. The LIT test was performed every day or every other day for patient group until death or discharge from units where the study is conducted. The LIT test was performed only once for outpatient group on day of outpatient control.
Measurements of ROS production by luminometer:
ROS production was measured on clinical samples taken for routine testing. Briefly, 10μl samples of freshly obtained blood (obtained by venepuncture) was added to 100 microlitres phosphate buffered saline (PBS) containing phorbol 12-myristate 13-acetate (PMA; Sigma) and luminol. The solution was incubated for 10 minutes at 37.5 °C. Chemiluminescence was quantified after 10 minutes using handheld luminometer (3M, Clean-Trace, NG3) in relative light units (RLU). LIT scores as a correlate of neutrophil function for each patient were plotted. Abnormally high (hyperproduction) ROS generation was associated with infection, sepsis or septic shock. This raises the possibility of LIT™ and LIT™/neutrophil-count ratio, (LIT/N), being used as a predictive clinical tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | – | Diagnostic Test: The Leukocyte ImmunoTest™ (LIT™)patients admitted to hospital with various infection conditions with or without sepsis |
| control group | – | Diagnostic Test: The Leukocyte ImmunoTest™ (LIT™)patients admitted to hospital with various non-infectious diseases and outpatients who admitted to the outpatient clinics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population is consisted of patients who were admitted to the ICU or inward due various infectious etiologies. The control population is consisted of outpatients or inpatients admitted to ICU or inward for noninfectious etiologies.
Key inclusion criteria (2 listed)
- Diagnosis or suspicion of various infectious disease with or without sepsis and admitted to the ICU or inpatient service due to this clinical diagnosis for patient group
- Patients followed in the inpatient service due to various non-infectious diseases and outpatients who were examined in outpatient clinics for control group
Key exclusion criteria (7 listed)
- patient or control group under the age of 18 years
- Patients died within the 24 hours after hospital admission
- Patients who did not sign informed consent
- Refusal of legal representative to participate in the study in unconscious patients
- Patients with an absolute neutrophil count <500/mm3 on admission
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 |
|---|---|---|
| The Leukocyte ImmunoTest™ (LIT™)The baseline LIT scores was performed for two parallel groups. The sequential LIT score was also performed for patients with various infection conditions with/without sepsis. | Diagnostic test | control group, patient group |
Primary outcome
the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)
Time frame: Patients' LIT scores in relative light units (RLU) within 24 hours following the day of hospitalization during the study period
the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between patients with various infection conditions and control groups without infection. Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with infection. LIT scores as relative light unit (RLU) can vary between 1-15000.
the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)
Time frame: LIT score as as relative light unit (RLU) of the day of detecting of infection and sepsis up to 8 months
the difference of the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) between patients between sepsis and without sepsis Abnormally high (hyperproduction) ROS generation demonstrated via The Leukocyte ImmunoTest™ (LIT) is associated with sepsis and septic shock. LIT scores as relative light unit (RLU) can vary between 1-15000.
1 secondary outcome
the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT)
Time frame: the Leukocyte ImmunoTest™ (LIT) as relative light unit (RLU) of the patients with sepsis on every day or every other day up to death or discharge from the hospital through the study completion, an average of 8 months
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 1 Aug 2023.
- Background: PubMed 30356867Mortaz E, Alipoor SD, Adcock IM, Mumby S, Koenderman L. Update on Neutrophil Function in Severe Inflammation. Front Immunol. 2018 Oct 2;9:2171. doi: 10.3389/fimmu.2018.02171. eCollection 2018.
- Background: PubMed 28149530Selders GS, Fetz AE, Radic MZ, Bowlin GL. An overview of the role of neutrophils in innate immunity, inflammation and host-biomaterial integration. Regen Biomater. 2017 Feb;4(1):55-68. doi: 10.1093/rb/rbw041.
- Background: PubMed 29682724Hellebrekers P, Vrisekoop N, Koenderman L. Neutrophil phenotypes in health and disease. Eur J Clin Invest. 2018 Nov;48 Suppl 2(Suppl Suppl 2):e12943. doi: 10.1111/eci.12943. Epub 2018 May 25.
- Background: PubMed 34599691Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
- Background: PubMed 24717459Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330.
- Background: PubMed 32503670Pierrakos C, Velissaris D, Bisdorff M, Marshall JC, Vincent JL. Biomarkers of sepsis: time for a reappraisal. Crit Care. 2020 Jun 5;24(1):287. doi: 10.1186/s13054-020-02993-5.
- Background: PubMed 32572531Fleischmann-Struzek C, Mellhammar L, Rose N, Cassini A, Rudd KE, Schlattmann P, Allegranzi B, Reinhart K. Incidence and mortality of hospital- and ICU-treated sepsis: results from an updated and expanded systematic review and meta-analysis. Intensive Care Med. 2020 Aug;46(8):1552-1562. doi: 10.1007/s00134-020-06151-x. Epub 2020 Jun 22.
- Background: PubMed 32374861Rhee C, Chiotos K, Cosgrove SE, Heil EL, Kadri SS, Kalil AC, Gilbert DN, Masur H, Septimus EJ, Sweeney DA, Strich JR, Winslow DL, Klompas M. Infectious Diseases Society of America Position Paper: Recommended Revisions to the National Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Sepsis Quality Measure. Clin Infect Dis. 2021 Feb 16;72(4):541-552. doi: 10.1093/cid/ciaa059.
- Background: PubMed 11240971Biomarkers Definitions Working Group.. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001 Mar;69(3):89-95. doi: 10.1067/mcp.2001.113989. No abstract available.
- Background: PubMed 35729319Veenith T, Martin H, Le Breuilly M, Whitehouse T, Gao-Smith F, Duggal N, Lord JM, Mian R, Sarphie D, Moss P. High generation of reactive oxygen species from neutrophils in patients with severe COVID-19. Sci Rep. 2022 Jun 21;12(1):10484. doi: 10.1038/s41598-022-13825-7.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
Nazlıhan Boyacı Dündar, assist.prof. principal investigator
principle investigator
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 Infections and Sepsis, run by Gazi University 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 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: finished, as of the sponsor's last update on 1 Aug 2023. 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?
the reactive oxygen species (ROS) production of neutrophils via the Leukocyte ImmunoTest™ (LIT) (time frame: Patients' LIT scores in relative light units (RLU) within 24 hours following the day of hospitalization during the study period). The study lists 2 primary outcomes in all. 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 NCT05968287, which also lists 11 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 1 Aug 2023.