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

NCT ID: NCT04295278

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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

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Multiple Organ Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic inflammatory response syndrome

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

MicroKine Dx system

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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MicroKine Dx system

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

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
Minimum Eligible Age

38 Weeks

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PreDxion Bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Information

Role: STUDY_DIRECTOR

PreDxion Bio, Inc.

Central Contacts

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Clinical Trial Information

Role: CONTACT

(650) 877-2309‬

Other Identifiers

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PDXN-BP-001

Identifier Type: -

Identifier Source: org_study_id

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