An observational study in Systemic Inflammatory Response Syndrome, sponsored by Phoenix Children's Hospital. Recruiting at 2 sites in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2025-11-12.
Sponsored by Phoenix Children's Hospital · Observational
Among 39 studies in Systemic Inflammatory Response Syndrome with a site in United States — 4 open to participants now, 7 under way, none of them phase 3. Systemic Inflammatory Response Syndrome · United States.
Among the 39 studies in Systemic Inflammatory Response Syndrome with a site in United States, this one is the 18th largest by planned enrollment of the 18 observational ones, is one of 3 that started in 2014, is one of 18 observational ones, and was the 16th registered.
195 studies on the registry are indexed under Systemic Inflammatory Response Syndrome; 24 are open to participants now.
This study's planned enrollment of 50 is below the median of 134 across 94 observational studies indexed under Systemic Inflammatory Response Syndrome.
Browse Systemic Inflammatory Response Syndrome studies →4 of the 39 studies in Systemic Inflammatory Response Syndrome with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 20 Systemic Inflammatory Response Syndrome studies recruiting now, 13 (65%) set no upper age limit and 4 (20%) stop at 75 or younger; 5 take children under 18; 0 take healthy volunteers.
This study: 1 Year to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →39 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 3 started in 2014.
Median enrollment 100 across the 21 interventional studies, 165 across the 18 observational. Of the 28 that completed or were terminated, 9 (32%) have results posted.
16 of 39 have an industry lead sponsor. The 10 most frequent:
Phoenix Children's Hospital is the lead sponsor of 42 studies on the registry; 8 are open to participants now.
Phoenix Children's Hospital has 1 study filed under Systemic Inflammatory Response Syndrome — fewer than ten, so there is no comparison to draw.
5 of the studies in Systemic Inflammatory Response Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07425587Bluejay Diagnostics, Inc.Multicenter Symphony™ IL-6 Monitoring Sepsis ED Pilot Study | 2026-12-30 |
| NCT06654895Bluejay Diagnostics, Inc.Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study | 2026-12-31 |
| NCT07221630Akron Children's HospitalConventional Ultrafiltration Versus Dilutional Ultrafiltration in Pediatric CPB Patients | 2026-12-31 |
| NCT02055105Phoenix Children's HospitalModulation of Molecular Fingerprinting in Pediatric Sepsis | 2027-06 |
| NCT05977153The University of Texas Medical Branch, GalvestonCT for Personalized Mechanical Ventilation | 2027-08-31 |
Among the 39 studies in Systemic Inflammatory Response Syndrome with a site in United States, from their registry updates:
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.
This study will aid in the evaluation of determining the accuracy of these miRNAs in pediatric patients and help in establishing pilot data for additional studies in the future. The testing will include blood samples, urine samples and buccal swabs from patients who meet eligibility at 5 time points to analyze biomarkers. Study participants will receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support per the clinical team. The samples will collected and stored at -80 until analysis can be performed. In addition to, during the course of the hospitalization, the enrolled patient will have data collected to calculate severity scores, including updated Pediatric Risk of Mortality (PRISM III) scores and simplified Therapeutic Intervention Scoring System(TISS-28) scores. All patient information will be de-identified. A standard procedure manual will be developed detailing the methods for data collection and entry. Data will be recorded in a de-identified manner on a Microsoft Excel database on a secure institutional server by the institutional staff. Data will then be analyzed to determine correlation of biomarkers to morbidity and mortality for these patients.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Previously healthy, non-immunocompromised patients, between the ages of 1 and 18, who are being admitted to the PCH PICU for sepsis or septic shock, will be enrolled. Blood samples, urine samples and buccal swabs will be obtained from these patients at 5 time points to analyze biomarkers. Study participants will receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support per the clinical team. The samples will collected and stored at -80 until analysis can be performed. In addition to, during the course of the hospitalization, the enrolled patient will have data collected to calculate severity scores, including PRISM scores and TISS-28 scores. All patient information will be de-identified. A standard procedure manual will be developed detailing the methods for data collection and entry.
Procedure: miRNA in Sepsis
Healthy non-immunocompromised patients between 1-18 years old
miRNA in Sepsis
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
Organ Failure
Will compare sequential organ failure assessment (SOFA) scores throughout hospitalization.
Time frame: Duration of hospital stay, an expected average of 3 weeks
Organ Dysfunction
Will compare pediatric multiple organ dysfunction scores (PMODS) throughout hospitalization
Time frame: Duration of hospital stay, an expected average of 3 weeks
Patient acuity
Will assess TISS-28 scores throughout hospitalization.
Time frame: Duration of hospital stay, an expected average of 3 weeks
Plan to share: Undecided — Principal investigator is undecided if he plans on having a DTA or MTA.
No publications or documents are linked to this record.
The record gives a start of Mar 2014, a primary completion of Jun 2027 and a completion of Oct 2027. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
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Systemic Inflammatory Response Syndrome →
Phoenix Children's Hospital