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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic inflammatory response syndrome | Systemic inflammatory response syndrome in patients in the pediatric intensive care unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroKine Dx system | Diagnostic Test | Biomarker concentrations will be determined using the MicroKine Dx system and results will be compared to measurements taken using standard immunoassays. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28-day in hospital mortality | 28-day |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Pediatric critically-ill patients 38-weeks gestation to 21 years of age admitted to a pediatric intensive care unit within the last 24-hours, with >1 indwelling central catheter, and meeting ≥2 age-adapted SIRS criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information | Contact | (650) 877-2309 | clinicaltrials@predxionbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Information | PreDxion Bio, Inc. | Study Director |
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| ID | Term |
|---|---|
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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plasma, serum