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

PreDxion Bio

Status: Unknown

Conditions: Multiple Organ Failure

Treatments: Diagnostic Test: MicroKine Dx system

Study type: Observational

Funder types: Industry

Identifiers

NCT04295278

PDXN-BP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 38 weeks to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.

Trial design

25 participants in 1 patient group

Systemic inflammatory response syndrome

Description:

Systemic inflammatory response syndrome in patients in the pediatric intensive care unit.

Treatment:

Diagnostic Test: MicroKine Dx system