NCT04295278

Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.

An Observational Phase 0 Study to Assess the Performance and Real-world Feasibility of Implementing the MicroKine Dx Biomarker-based Risk Stratification of Critically-ill Pediatric Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: PreDxion Bio, Inc. · Industry
• Sex: All
• Age: 38 Weeks – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Organ Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MicroKine Dx system	Biomarker concentrations will be determined using the MicroKine Dx system and results will be compared to measurements taken using standard immunoassays.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2020-03-04
• Last updated: 2020-09-16

Regulatory

• FDA-regulated device study