Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.
- Conditions
- Multiple Organ Failure
- Interventions
- Diagnostic Test: MicroKine Dx system
- Registration Number
- NCT04295278
- Lead Sponsor
- PreDxion Bio, Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
- Age 38 weeks gestation to 21 years of age
- Admitted to the PICU within the prior 24 hours
- Indwelling catheters for obtaining blood
- Meet ≥2 age-adapted SIRS criteria
Key
- Anticipated pediatric intensive care unit admission <24 hours
- Primary immunodeficiency
- Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Systemic inflammatory response syndrome MicroKine Dx system Systemic inflammatory response syndrome in patients in the pediatric intensive care unit.
- Primary Outcome Measures
Name Time Method Mortality 28-day 28-day in hospital mortality
- Secondary Outcome Measures
Name Time Method