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

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Sponsor:

Information provided by (Responsible Party):

Michal Fedora, Brno University Hospital

Study Description

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.

Study Design

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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

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 :

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?

Eligibility Criteria

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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

Contacts and Locations

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

More Information

Publications:

Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. Review.

De Blasi RA, Cardelli P, Costante A, Sandri M, Mercieri M, Arcioni R. Immature platelet fraction in predicting sepsis in critically ill patients. Intensive Care Med. 2013 Apr;39(4):636-43. doi: 10.1007/s00134-012-2725-7. Epub 2012 Oct 24.

Nierhaus A, Klatte S, Linssen J, Eismann NM, Wichmann D, Hedke J, Braune SA, Kluge S. Revisiting the white blood cell count: immature granulocytes count as a diagnostic marker to discriminate between SIRS and sepsis--a prospective, observational study. BMC Immunol. 2013 Feb 12;14:8. doi: 10.1186/1471-2172-14-8.

Liu Y, Hou JH, Li Q, Chen KJ, Wang SN, Wang JM. Biomarkers for diagnosis of sepsis in patients with systemic inflammatory response syndrome: a systematic review and meta-analysis. Springerplus. 2016 Dec 12;5(1):2091. doi: 10.1186/s40064-016-3591-5. eCollection 2016.

Enz Hubert RM, Rodrigues MV, Andreguetto BD, Santos TM, de Fátima Pereira Gilberti M, de Castro V, Annichino-Bizzacchi JM, Dragosavac D, Carvalho-Filho MA, De Paula EV. Association of the immature platelet fraction with sepsis diagnosis and severity. Sci Rep. 2015 Jan 26;5:8019. doi: 10.1038/srep08019.

Schaer C, Schmugge M, Frey B. Prognostic value of nucleated red blood cells in critically ill children. Swiss Med Wkly. 2014 Mar 28;144:w13944. doi: 10.4414/smw.2014.13944. eCollection 2014.

Straney L, Clements A, Parslow RC, Pearson G, Shann F, Alexander J, Slater A; ANZICS Paediatric Study Group and the Paediatric Intensive Care Audit Network. Paediatric index of mortality 3: an updated model for predicting mortality in pediatric intensive care*. Pediatr Crit Care Med. 2013 Sep;14(7):673-81. doi: 10.1097/PCC.0b013e31829760cf.

Leteurtre S, Duhamel A, Salleron J, Grandbastien B, Lacroix J, Leclerc F; Groupe Francophone de Réanimation et d'Urgences Pédiatriques (GFRUP). PELOD-2: an update of the PEdiatric logistic organ dysfunction score. Crit Care Med. 2013 Jul;41(7):1761-73. doi: 10.1097/CCM.0b013e31828a2bbd.

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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

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