Algorithm for Predicting the Unfavorable Course of Sepsis in Children (NCT05908162) | Clinical Trial Compass
CompletedNot Applicable
Algorithm for Predicting the Unfavorable Course of Sepsis in Children
Belarus185 participantsStarted 2021-07-01
Plain-language summary
A comprehensive strategy will be used to investigate the relationship and correlation between 4 diagnostically significant markers relevant for early diagnosis and prediction of complications and death in the development of sepsis in children (C-reactive protein, procalcitonin, presepsin and lipopolysaccharide binding protein). For the first time, an attempt will be made to assess the genetic characteristics of the patient's from the point of view of predisposition to the unfavorable development of the sepsis based on the study of polymorphism of a number of genes of the immune system (tumor necrosis factor beta; interleukin 6, 8, 10; lymphotoxin alpha, etc.).
Based on the study results, an algorithm to predict the unfavorable course of sepsis in children will be developed using a comprehensive assessment of biochemical and molecular genetic markers.
Who can participate
Age range
1 Day – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
Timeframe: 1 month
2
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
Timeframe: 1 month
Trial details
NCT IDNCT05908162
SponsorThe Republican Research and Practical Center for Epidemiology and Microbiology