Early Identification of Sepsis in Children
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedDecember 3, 2019
December 1, 2019
2 years
March 15, 2019
December 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IG and IPF concentration for early sepsis identification
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.
7 days
Secondary Outcomes (3)
IG serum levels in patients with SIRS and sepsis/severe sepsis/septic shock
7 days
IPF serum levels in patients with SIRS and sepsis/severe sepsis/septic shock
7 days
NRBC cell count and critically ill patient´s outcome
7 days
Study Arms (5)
No SIRS
Children without clinical signs of SIRS, according to Goldstein criteria.
SIRS
Children with clinical signs of SIRS, according to Goldstein criteria.
Sepsis
Children with clinical signs of sepsis, according to Goldstein criteria.
Severe sepsis
Children with clinical signs of severe sepsis, according to Goldstein criteria.
Septic Shock
Children with clinical signs of septic shock, according to Goldstein criteria.
Interventions
Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.
Eligibility Criteria
Children admitted to PICU.
You may qualify if:
- all patients admitted to PICU until the 18th year of age
- expected length of stay \> 48 hours
You may not qualify if:
- oncology patients
- immunosuppressive therapy
- immunostimulant therapy
- autoimmune disease
- post-organ transplant patient
- thrombocytopaenia, thrombocytopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Brno
Brno, 61300, Czechia
Related Publications (8)
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. doi: 10.1097/01.PCC.0000149131.72248.E6.
PMID: 15636651BACKGROUNDDe 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.
PMID: 23093245BACKGROUNDNierhaus 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.
PMID: 23398965BACKGROUNDLiu 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.
PMID: 28028489BACKGROUNDEnz Hubert RM, Rodrigues MV, Andreguetto BD, Santos TM, de Fatima 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.
PMID: 25620275BACKGROUNDSchaer 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.
PMID: 24706413BACKGROUNDStraney 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.
PMID: 23863821BACKGROUNDLeteurtre S, Duhamel A, Salleron J, Grandbastien B, Lacroix J, Leclerc F; Groupe Francophone de Reanimation et d'Urgences Pediatriques (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.
PMID: 23685639BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petr Dominik, MD.
University Hospital Brno
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. prof. Michal Fedora, MD., Ph.D.
Study Record Dates
First Submitted
March 15, 2019
First Posted
March 21, 2019
Study Start
December 1, 2019
Primary Completion
December 1, 2021
Study Completion
January 1, 2022
Last Updated
December 3, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share