Algorithm to predict severe outcomes of sepsis in children
To Develop an Algorithm for Predicting the Unfavorable Course of Sepsis in Children Based on a Comprehensive Assessment of Immunological, Biochemical and Molecular Genetic Markers
This study is trying to see if certain biological markers and genetic factors can help predict serious complications in children with sepsis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 89 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | The Republican Research and Practical Center for Epidemiology and Microbiology Academic / other |
| Locations | 1 site (Minsk) |
| Trial ID | NCT05908162 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between four key biomarkers and genetic factors that may predict complications and mortality in pediatric sepsis. It will analyze biochemical markers, immune status, and genetic polymorphisms in children diagnosed with sepsis, comparing these findings with a control group. The study will also assess the cellular immunity and levels of pro-inflammatory cytokines to develop a predictive algorithm for unfavorable sepsis outcomes. By correlating clinical and laboratory data, the research seeks to enhance early diagnosis and treatment strategies for sepsis in children.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 month to 18 years who have a confirmed septic process.
Not a fit: Patients over 18 years old or those with chronic mental disorders, severe chronic diseases, or active infections like HIV or tuberculosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and treatment strategies for children with sepsis, potentially reducing complications and mortality.
How similar studies have performed: Other studies have shown promise in using biomarkers for predicting sepsis outcomes, but this specific approach combining genetic factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age from 1 month to 18 years; * confirmed septic process$ * informed consent. Exclusion Criteria: * age from 18 years; * refuse of patient to participate in the trial; * chronic mental disorders with severe manifestations; * pregnancy/lactation; * intercurrent severe chronic diseases; * HIV, Hepatites B/C; * active tuberculosis; * cachexia of any origin; * malignant neoplasms.
Where this trial is running
Minsk
- City Children's Infectious Clinical Hospital — Minsk, Belarus (Recruiting)
Study contacts
- Principal investigator: Elena G Fomina, Dr — The Republican Research and Practical Center for Epidemiology and Microbiology (RRPCEM)
- Study coordinator: Oksana N Romanova, Dr
- Email: romox@tut.by
- Phone: +375172022505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.