Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.
NCT ID: NCT04295278
Last Updated: 2020-09-16
Study Results
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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UNKNOWN
25 participants
OBSERVATIONAL
2021-01-31
2022-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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.
Eligibility Criteria
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Inclusion Criteria
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
2. Primary immunodeficiency
3. Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care
38 Weeks
21 Years
ALL
No
Sponsors
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PreDxion Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Information
Role: STUDY_DIRECTOR
PreDxion Bio, Inc.
Central Contacts
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Other Identifiers
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PDXN-BP-001
Identifier Type: -
Identifier Source: org_study_id
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