Health TrialsbyHealthPanel

Modulation of Molecular Fingerprinting in Pediatric Sepsis

ConditionSystemic Inflammatory Response Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorPhoenix Children's Hospital

About this trial

The goal of this study is to demonstrate the sensitivity and specificity of detecting circulating micro RNA (miRNA) biomarkers in pediatric septic patients. It will also follow expression and modulation of levels in response to therapy in comparison to current biomarkers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 1 through 18 years

Patients admitted to the PICU with concerns for sepsis or those developing sepsis during their admission to the hospital.

Patients must be enrolled int he study from arrival time tot he ED up to 24 hours from the time of initiation of antibiotic therapy for treatment of sepsis or septic shock.

Signed informed consent.

Disqualifiers

Patients <1 year of age and greater than 18 years of age.

Trial population

Children ages 1-18 who are Immune-competent (no previous chronic medical conditions) patients being admitted to the PICU at PCH with concerns for sepsis or those developing sepsis during their admission to the hospital who require care in the PICU.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • miRNA in Sepsis

    Procedure/Surgery

    miRNA in Sepsis

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: 10 Patients with sepsis or septic shock1 intervention
Group B: 50 Healthy Patients0 interventions

Trial outcomes

Primary outcomes

1

Risk of Mortality

Will compare PRISM 3 scores from baseline to hospital discharge.

Time frame
Duration of hospital stay, an expected average of 3 weeks

Secondary outcomes

1

Organ Failure

Will compare sequential organ failure assessment (SOFA) scores throughout hospitalization.

Time frame
Duration of hospital stay, an expected average of 3 weeks
2

Organ Dysfunction

Will compare pediatric multiple organ dysfunction scores (PMODS) throughout hospitalization

Time frame
Duration of hospital stay, an expected average of 3 weeks
3

Patient acuity

Will assess TISS-28 scores throughout hospitalization.

Time frame
Duration of hospital stay, an expected average of 3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Phoenix Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
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