Sepsis Clinical Trial
Official title:
Early Identification of Sepsis in Children
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Brno | Brno |
Lead Sponsor | Collaborator |
---|---|
Brno University Hospital |
Czechia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | IG serum levels in patients with SIRS and sepsis/severe sepsis/septic shock | 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. | 7 days | |
Secondary | IPF serum levels in patients with SIRS and sepsis/severe sepsis/septic shock | 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. | 7 days | |
Secondary | NRBC cell count and critically ill patient´s outcome | 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? | 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05095324 -
The Biomarker Prediction Model of Septic Risk in Infected Patients
|
||
Completed |
NCT02714595 -
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
|
Phase 3 | |
Completed |
NCT03644030 -
Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
|
||
Completed |
NCT02867267 -
The Efficacy and Safety of Ta1 for Sepsis
|
Phase 3 | |
Completed |
NCT04804306 -
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
|
||
Recruiting |
NCT05578196 -
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
|
N/A | |
Terminated |
NCT04117568 -
The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
|
||
Completed |
NCT03550794 -
Thiamine as a Renal Protective Agent in Septic Shock
|
Phase 2 | |
Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
Completed |
NCT04227652 -
Control of Fever in Septic Patients
|
N/A | |
Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
Recruiting |
NCT04005001 -
Machine Learning Sepsis Alert Notification Using Clinical Data
|
Phase 2 | |
Completed |
NCT03258684 -
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock
|
N/A | |
Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
Completed |
NCT05018546 -
Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery
|
N/A | |
Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
Not yet recruiting |
NCT06045130 -
PUFAs in Preterm Infants
|
||
Not yet recruiting |
NCT05361135 -
18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia
|
N/A | |
Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 |