Status:
UNKNOWN
Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.
Lead Sponsor:
PreDxion Bio, Inc.
Conditions:
Multiple Organ Failure
Eligibility:
All Genders
38-21 years
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 man...
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 pedia...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04295278
Start Date
January 1 2021
End Date
December 1 2022
Last Update
September 16 2020
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