Multiple Organ Failure
Conditions
Brief summary
This study will enroll approximately 25 pediatric patients to assess the performance and real-world feasibility of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.
Detailed description
This study will enroll approximately 25 pediatric patients to assess the predictive performance of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients. All enrolled patients will undergo a series of blood collection procedures during their admission to the pediatric intensive care unit. The levels of inflammatory cytokines, chemokines, and effectors will be assessed and used in multi-biomarker based prognostic and predictive algorithms to determine patients at risk of in-hospital mortality.
Interventions
DIAGNOSTIC_TESTMicroKine Dx system
Biomarker concentrations will be determined using the MicroKine Dx system and results will be compared to measurements taken using standard immunoassays.
Sponsors
PreDxion Bio, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
38 Weeks to 21 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Age 38 weeks gestation to 21 years of age 2. Admitted to the PICU within the prior 24 hours 3. Indwelling catheters for obtaining blood 4. Meet ≥2 age-adapted SIRS criteria Key
Exclusion criteria
1. Anticipated pediatric intensive care unit admission \<24 hours 2. Primary immunodeficiency 3. Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 28-day | 28-day in hospital mortality |
Contacts
Primary ContactClinical Trial Information
Outcome results
None listed