R65.1
Conditions
Interventions
Group 1: In 40 infants and toddlers (50 newobrns (birth-d28), 50 infants (d29 - <1 year) and 50 toddlers (1year – 5 years) with suspected or proven severe sepsis or septic shock (according to the pedi
Sponsors
Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
No minimum to 5 Years
Inclusion criteria
Inclusion criteria: - Age = 0 days and <6 years - Informed consent by parent(s) or legal guardian Severe Sepsis (with an onset =24h): - Infants and toddlers with severe sepsis can be identified with a clinical construct of sepsis (Infection + = 2 criteria of a systemic inflammatory syndrome (SIRS)) together with clinical signs of an organ failure. or Septic shock (with an onset =24h): - Infants and toddlers with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP = 40 mmHg+1,5mmHg x age [years]) despite adequate volume resuscitation
Exclusion criteria
Exclusion criteria: - Age = 6 years - Refusal to participate in the study by the legal guardian - Patients who have already been included and need to be readmitted to the ICU cannot be included a second time - It is either not possible to take the blood samples required for the study or the attending physicians do not consider it justifiable in individual cases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the evaluation of NGS-performance (sensitivity, specificity, positive predictive value, negative predictive value), results of the NGS-based approach for each sample will be compared with those obtained using conventional microbiology methods for the same sample. Moreover, interobserver agreement will be assessed by the calculation of Cohens Kappa. The clinical value of the NGS-based approach will be estimated by a panel of three independent clinical specialists not associated with the study site, retrospectively identifying potential changes in patients´ management based on NGS results. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.) Diagnostic or prognostic value of host nucleosome positioning patterns derived from plasma cell free DNA in infants and toddlers with suspected or proven severe sepsis or septic shock, 2.) Diagnostic value of host expression profiles including RNA-derived biomarkers in infants and toddlers with suspected or proven severe sepsis or septic shock, 3.) Diagnostic or prognostic value of methylglyoxal (MG)-derived carbonylstress in infants and toddlers with suspected or proven severe sepsis or septic shock, 4.) Evaluation of antimicrobial resistance patterns and virulence factors, 5.) Evaluation of process times for NGS-based measurements | — |
Countries
Germany
Contacts
Public ContactThorsten Brenner
Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Essen
Outcome results
None listed