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Early Identification of Sepsis in Children

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ClinicalTrials.gov Identifier: NCT03884595
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Michal Fedora, Brno University Hospital

Brief Summary:
This observational nation-wide study is focused on evaluation of the new possible biomarkers for pediatric sepsis and their specificity/sensitivity in combination with usual diagnostic markers for sepsis in the terms of early identification of sepsis, severe sepsis, and septic shock.

Condition or disease Intervention/treatment
Sepsis Shock, Septic Sepsis, Severe SIRS Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin

Detailed Description:

The understanding of sepsis pathophysiology underwent a great progress during the last decades and the therapy of sepsis is in the focus of the research for many years, but sepsis is still one of the main causes of death in the ICUs around the world. Systemic inflammatory response syndrome (SIRS) is closely connected with the sepsis development, but SIRS also represents a high risk of organ dysfunction in non-infectious patients (trauma, stress, cardiopulmonary arrest). Early diagnosis and prevention of the organ dysfunction are the mainstay of the correct and timely therapy, but currently there is no reliable, quick and simple method for the diagnosis of sepsis. And also there is no generally accepted clinical or laboratory parameter, which can be used to differentiate between sepsis and SIRS.

There are some commonly available biomarkers that showed promising results in critically ill adult patients. Those include immature platelet fraction (IPF), immature granulocytes (IG) count and nucleated red blood cells (NRBC) count. The knowledge of their variability in different phases of illness (SIRS/sepsis/severe sepsis/septic shock) in pediatric patients is very limited, as is their connection with other generally used markers of infection (CRP, procalcitonin, presepsin).

This study is strictly non-interventional and focused on usability of above mentioned biomarkers in the early diagnosis of sepsis/SIRS and on the reduction of morbidity/mortality of pediatric intensive care unit (PICU) patients with sepsis/SIRS.

In all patients admitted to PICU in selected study period, the inflammation markers - C-reactive protein (CRP), procalcitonin (PCT), presepsin (soluble cluster of differentiation 14-subtypes) and full blood count parameters -IPF,IG,NRBC will be measured at the time of admission and on 3rd, 5th and 7th day of stay in intensive care. The organ dysfunction score will be evaluated daily.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Identification of Sepsis in Children
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Group/Cohort Intervention/treatment
No SIRS
Children without clinical signs of SIRS, according to Goldstein criteria.
Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.

SIRS
Children with clinical signs of SIRS, according to Goldstein criteria.
Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.

Sepsis
Children with clinical signs of sepsis, according to Goldstein criteria.
Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.

Severe sepsis
Children with clinical signs of severe sepsis, according to Goldstein criteria.
Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.

Septic Shock
Children with clinical signs of septic shock, according to Goldstein criteria.
Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.




Primary Outcome Measures :
  1. IG and IPF concentration for early sepsis identification [ Time Frame: 7 days ]
    The levels of IG and IPF will be obtained in first 7 days after admission. The IG and IPF will be evaluated for the possibility of early sepsis recognition.


Secondary Outcome Measures :
  1. IG serum levels in patients with SIRS and sepsis/severe sepsis/septic shock [ Time Frame: 7 days ]
    The levels of IG will be obtained in first 7 days after admission. The IG will be evaluated for the possibility of distinguish patients with or without SIRS and sepsis/severe sepsis/septic shock sepsis/septic shock.

  2. IPF serum levels in patients with SIRS and sepsis/severe sepsis/septic shock [ Time Frame: 7 days ]
    The levels of IPF will be obtained in first 7 days after admission. The IPF will be evaluated for the possibility of distinguish patients with or without SIRS and sepsis/severe sepsis/septic shock sepsis/septic shock.

  3. NRBC cell count and critically ill patient´s outcome [ Time Frame: 7 days ]
    The NRBC count will be obtained in first 7 days after admission. The NRBC count will be evaluated for the possibility correlation with the outcome (mortality and morbidity) of critically ill paediatric patients in PICU sepsis/septic shock?



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children admitted to PICU.
Criteria

Inclusion Criteria:

  • all patients admitted to PICU until the 18th year of age
  • expected length of stay > 48 hours

Exclusion Criteria:

  • oncology patients
  • immunosuppressive therapy
  • immunostimulant therapy
  • autoimmune disease
  • post-organ transplant patient
  • thrombocytopaenia, thrombocytopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884595


Contacts
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Contact: Michal Fedora, MD., Ph.D. +420532234698 fedora.michal@fnbrno.cz
Contact: Jozef Klucka, MD. +420532234696 klucka.jozef@fnbrno.cz

Locations
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Czechia
University Hospital Brno Recruiting
Brno, Czechia, 61300
Contact: Michal Fedora, MD., Ph.D.    +420532234698    fedora.michal@fnbrno.cz   
Contact: Jozef Klučka, MD.    +420532234696    klucka.jozef@fnbrno.cz   
Principal Investigator: Petr Dominik, MD.         
Sponsors and Collaborators
Brno University Hospital
Investigators
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Principal Investigator: Petr Dominik, MD. University Hospital Brno
Publications:

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Responsible Party: Michal Fedora, Assoc. prof. Michal Fedora, MD., Ph.D., Brno University Hospital
ClinicalTrials.gov Identifier: NCT03884595    
Other Study ID Numbers: FNBRNO-2017/01
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michal Fedora, Brno University Hospital:
sepsis
septic shock
severe sepsis
SIRS
children
immature platelet fraction (IPF)
immature granulocytes (IG)
nucleated red blood cells (NRBC)
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock