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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

Tracking Information
First Submitted Date March 15, 2019
First Posted Date March 21, 2019
Last Update Posted Date December 3, 2019
Actual Study Start Date December 1, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 20, 2019)
  • 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.
  • 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.
  • 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?
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Identification of Sepsis in Children
Official Title Early Identification of Sepsis in Children
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children admitted to PICU.
Condition
  • Sepsis
  • Shock, Septic
  • Sepsis, Severe
  • SIRS
Intervention 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.
Study Groups/Cohorts
  • No SIRS
    Children without clinical signs of SIRS, according to Goldstein criteria.
    Intervention: Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
  • SIRS
    Children with clinical signs of SIRS, according to Goldstein criteria.
    Intervention: Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
  • Sepsis
    Children with clinical signs of sepsis, according to Goldstein criteria.
    Intervention: Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
  • Severe sepsis
    Children with clinical signs of severe sepsis, according to Goldstein criteria.
    Intervention: Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
  • Septic Shock
    Children with clinical signs of septic shock, according to Goldstein criteria.
    Intervention: Diagnostic Test: IG, IPF, NRBC, CRP, PCT, presepsin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 29, 2019)
100
Original Estimated Enrollment
 (submitted: March 20, 2019)
95
Estimated Study Completion Date January 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Michal Fedora, MD., Ph.D. +420532234698 fedora.michal@fnbrno.cz
Contact: Jozef Klucka, MD. +420532234696 klucka.jozef@fnbrno.cz
Listed Location Countries Czechia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03884595
Other Study ID Numbers FNBRNO-2017/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Michal Fedora, Brno University Hospital
Study Sponsor Brno University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Petr Dominik, MD. University Hospital Brno
PRS Account Brno University Hospital
Verification Date December 2019