Sepsis SyndromeNCT02643121
Utility of Presepsin in Children Sepsis
An observational study of Sepsis Syndrome, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Presepsin (formerly CD14), is a glycoprotein receptor occurring at the surface of monocytes/macrophages. CD14 binds to lipopolysaccharide (LPS) complexes and LPS binding protein (LPB), which triggers the activation of toll-like receptor 4 (TLR4), resulting in the production of numerous pro-inflammatory cytokines. Read more about this study
- Who is it for?
- Ages 1 month to 216 monthsHealthy volunteers can take part
- Conditions the study is for
- Sepsis Syndrome
- What is being tested?
- therapy sepsis
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2014to Jan 2017
- 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 1 month to 216 months
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Childrens with SIRS or septic state who will be admitted to the Department of Anesthesia and Intensive Care of the University Children´s Hospital Brno, Czech Republic. Infections, sepsis, severe sepsis, septic shock and multiple organ dysfunction syndrome (MODS) will be defined according to commonly used criteria - by International pediatric sepsis consensus conference. The samples from children undergoing elective surgery will be used as a controls, i.e. samples from patients without signs of infection.
Who may be able to join
- children aged 1 - 216 months
- clinical data to enable classification into sepsis or SIRS
- written informed consent by the legally authorized representative
- children aged 1 - 216 months
- does not meet clinical criteria for sepsis or SIRS
- written informed consent by the legally authorized representative
Who cannot join
- no informed consent
- Control
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic and Prognostic Utility of Presepsin for Sepsis and Systemic Inflammatory Response Syndrome in Children
Presepsin (formerly CD14), is a glycoprotein receptor occurring at the surface of monocytes/macrophages. CD14 binds to lipopolysaccharide (LPS) complexes and LPS binding protein (LPB), which triggers the activation of toll-like receptor 4 (TLR4), resulting in the production of numerous pro-inflammatory cytokines. Following Presepsin activation by bacterial products, the CD14 complex is released in the circulation as its soluble form (sCD14), which in turn is cleaved by a plasma protease to generate a sCD14 fragment called sCD14-subtype (sCD14- ST). Plasma levels of sCD14 can be measured using an automated chemo-luminescent assay (PATHFAST).
Read the detailed description
Severe sepsis and septic shock represent major challenges of modern intensive care medicine, and still recently published international guidelines demand ongoing research about the pathophysiology, diagnostics and treatment. Currently, the diagnosis of sepsis is based on the presence of systemic inflammatory response syndrome (SIRS) criteria in the presence of a known infection. However, non-infectious SIRS associated with acute tissue injury and innate immune activation can induce clinical syndromes analogous to sepsis, including multiple trauma, pancreatitis, burns, and autoimmune diseases.
Within the field of infectious diseases, a biomarker may be used for identifying a high risk group or predisposing condition, as an aid to identification of the disease, or to direct therapy and stratify patients according to their specific risk factors, and/or as an aid to therapeutic management in order to avoid relapse of infection. Within the recent years, dozens of potential biomarkers of infection have been described. The diagnostic performance of biomarkers is usually measured in terms of sensitivity, specificity, and by likelihood ratios and area under the ROC (Receiver Operating Characteristics) curves.
Recently, several researches devolved their interest in discovering pathways involved in the innate immunity. Mediators involved in the recognition and elimination of bacterial endotoxins have been identified as new candidate biomarkers of sepsis, namely lipopolysaccharide binding protein (LBP) and soluble fractions of the membrane cluster of differentiation 14 (mCD14). Membrane CD14 is a multifunctional glycosylphosphatidylinositol-anchored membrane protein (cell surface glycoprotein), constitutively expressed by various cells, including monocytes, macrophages, neutrophils, etc. CD14 is a pattern recognition receptor for bacterial molecules, namely lipopolysaccharides (LPS) from Gram-negative bacteria and peptidoglycans together with lipoteichoic acid from Gram-positive bacteria. CD14 is crucial in activating the toll-like receptor 4 (TLR4)-specific proinflammatory signaling cascade and ultimately, initiating the inflammatory reaction against invading microorganisms. In the course of inflammatory reaction, plasma protease activity generates soluble CD14 fragments (sCD14), presepsin.
- Conditions
- Sepsis Syndrome
- Being tested
- therapy sepsis
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapy sepsisOther
Treatment of sepsis varies depending on the site and cause of the initial infection, the organs affected and the extent of any damage
| Study group | Role | What they receive |
|---|---|---|
| children with sepsis, SIRS | Data will be collected and analyzed from childrens with SIRS or septic state who will be admitted to the Department of Anesthesia and Intensive Care of the University Children´s Hospital Brno, Czech Republic. Infections, sepsis, severe sepsis, septic shock and multiple organ dysfunction syndrome (MODS) will be defined according to commonly used criteria - by International pediatric sepsis consensus conference. Receives: Other: therapy sepsis | |
| control group, healthy children | The samples children undergoing elective surgery will be used as a controls, i.e. samples from patients without signs of infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of presepsin
Assessed the presepsin diagnostic accuracy of presepsin in diagnosing children sepsis and in discriminating systemic inflammatory response syndrome (SIRS) from sepsis. Diagnostic accuracies presented as area under the curve (AUC) for sCD14-ST.
Measured: up to 36 months
Secondary outcomes (1)
Prognostic value of presepsin
Preliminary reports suggest that levels of presepsin are significantly higher in septic patients than in healthy individuals. The aim of this study is to investigate the diagnostic and prognostic value of presepsin compared to other inflammatory markers in children with SIRS and suspected sepsis or septic shock. Receiver operating characteristic (ROC) curve analysis will performed for presepsin and compared to ROC curve analysis of current available infection biomarkers.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis SyndromeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiří Žurek, Brno University Hospital
- Investigators
- Jiří Žurek, M.D., Ph.D., Principal investigator, Department of Anesthesia and Intensive Care, University Children´s Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643121
- Sponsor's protocol ID
- KDAR 19 - 1
- Status last verified
- Dec 2015
- First submitted
- 8 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Utility of Presepsin for Sepsis and Systemic Inflammatory Response Syndrome in Children
- ClinicalTrials.gov ID
- NCT02643121
- Acronym / sponsor ID
- KDAR 19 - 1
- Conditions
- Sepsis Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 31 Dec 2015 (estimated)
- 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.
Presepsin (formerly CD14), is a glycoprotein receptor occurring at the surface of monocytes/macrophages. CD14 binds to lipopolysaccharide (LPS) complexes and LPS binding protein (LPB), which triggers the activation of toll-like receptor 4 (TLR4), resulting in the production of numerous pro-inflammatory cytokines. Following Presepsin activation by bacterial products, the CD14 complex is released in the circulation as its soluble form (sCD14), which in turn is cleaved by a plasma protease to generate a sCD14 fragment called sCD14-subtype (sCD14- ST). Plasma levels of sCD14 can be measured using an automated chemo-luminescent assay (PATHFAST).
Detailed description
Severe sepsis and septic shock represent major challenges of modern intensive care medicine, and still recently published international guidelines demand ongoing research about the pathophysiology, diagnostics and treatment. Currently, the diagnosis of sepsis is based on the presence of systemic inflammatory response syndrome (SIRS) criteria in the presence of a known infection. However, non-infectious SIRS associated with acute tissue injury and innate immune activation can induce clinical syndromes analogous to sepsis, including multiple trauma, pancreatitis, burns, and autoimmune diseases.
Within the field of infectious diseases, a biomarker may be used for identifying a high risk group or predisposing condition, as an aid to identification of the disease, or to direct therapy and stratify patients according to their specific risk factors, and/or as an aid to therapeutic management in order to avoid relapse of infection. Within the recent years, dozens of potential biomarkers of infection have been described. The diagnostic performance of biomarkers is usually measured in terms of sensitivity, specificity, and by likelihood ratios and area under the ROC (Receiver Operating Characteristics) curves.
Recently, several researches devolved their interest in discovering pathways involved in the innate immunity. Mediators involved in the recognition and elimination of bacterial endotoxins have been identified as new candidate biomarkers of sepsis, namely lipopolysaccharide binding protein (LBP) and soluble fractions of the membrane cluster of differentiation 14 (mCD14). Membrane CD14 is a multifunctional glycosylphosphatidylinositol-anchored membrane protein (cell surface glycoprotein), constitutively expressed by various cells, including monocytes, macrophages, neutrophils, etc. CD14 is a pattern recognition receptor for bacterial molecules, namely lipopolysaccharides (LPS) from Gram-negative bacteria and peptidoglycans together with lipoteichoic acid from Gram-positive bacteria. CD14 is crucial in activating the toll-like receptor 4 (TLR4)-specific proinflammatory signaling cascade and ultimately, initiating the inflammatory reaction against invading microorganisms. In the course of inflammatory reaction, plasma protease activity generates soluble CD14 fragments (sCD14), presepsin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with sepsis, SIRS | – | Other: therapy sepsisData will be collected and analyzed from childrens with SIRS or septic state who will be admitted to the Department of Anesthesia and Intensive Care of the University Children´s Hospital Brno, Czech Republic. Infections, sepsis, severe sepsis, septic shock and multiple organ dysfunction syndrome (MODS) will be defined according to commonly used criteria - by International pediatric sepsis consensus conference. |
| control group, healthy children | – | –The samples children undergoing elective surgery will be used as a controls, i.e. samples from patients without signs of infection. |
Who may qualify
- Ages
- 1 month to 216 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Childrens with SIRS or septic state who will be admitted to the Department of Anesthesia and Intensive Care of the University Children´s Hospital Brno, Czech Republic. Infections, sepsis, severe sepsis, septic shock and multiple organ dysfunction syndrome (MODS) will be defined according to commonly used criteria - by International pediatric sepsis consensus conference. The samples from children undergoing elective surgery will be used as a controls, i.e. samples from patients without signs of infection.
Key inclusion criteria (6 listed)
- children aged 1 - 216 months
- clinical data to enable classification into sepsis or SIRS
- written informed consent by the legally authorized representative
- children aged 1 - 216 months
- does not meet clinical criteria for sepsis or SIRS
Key exclusion criteria (3 listed)
- no informed consent
- Control
- no informed consent
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 |
|---|---|---|
| therapy sepsisTreatment of sepsis varies depending on the site and cause of the initial infection, the organs affected and the extent of any damage | Other | children with sepsis, SIRS |
Primary outcome
Diagnostic accuracy of presepsin
Time frame: up to 36 months
Assessed the presepsin diagnostic accuracy of presepsin in diagnosing children sepsis and in discriminating systemic inflammatory response syndrome (SIRS) from sepsis. Diagnostic accuracies presented as area under the curve (AUC) for sCD14-ST.
1 secondary outcome
Prognostic value of presepsin
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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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.
Jiří Žurek, M.D., Ph.D. principal investigator
Department of Anesthesia and Intensive Care, University Children´s Hospital
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 Syndrome, run by Brno University Hospital at 1 site in Czechia.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Jan 2016. 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 Czechia. 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?
Results are not available in the source record.
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?
Diagnostic accuracy of presepsin (time frame: up to 36 months). 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 1 Jan 2016.