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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 Patients with sepsis or septic shock | 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. |
| |
| 50 Healthy Patients | Healthy non-immunocompromised patients between 1-18 years old |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miRNA in Sepsis | Procedure | miRNA in Sepsis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Mortality | Will compare PRISM 3 scores from baseline to hospital discharge. | Duration of hospital stay, an expected average of 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Organ Failure | Will compare sequential organ failure assessment (SOFA) scores throughout hospitalization. | Duration of hospital stay, an expected average of 3 weeks |
| Organ Dysfunction | Will compare pediatric multiple organ dysfunction scores (PMODS) throughout hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederick A Willyerd, MD | Contact | 6029331784 | fwillyerd@phoenixchildrens.com | |
| Althaia Calla G Ignacio, BSN, MD | Contact | 6029333795 | aignacio@phoenixchildrens.com |
| Name | Affiliation | Role |
|---|---|---|
| Frederick A Willyerd, MD | Phoenix Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
Principal investigator is undecided if he plans on having a DTA or MTA.
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D035683 | MicroRNAs |
| ID | Term |
|---|---|
| D016372 | RNA, Antisense |
| D016375 | Antisense Elements (Genetics) |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012313 | RNA |
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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.
| Duration of hospital stay, an expected average of 3 weeks |
| Patient acuity | Will assess TISS-28 scores throughout hospitalization. | Duration of hospital stay, an expected average of 3 weeks |
| Phoenix Children's Hospital | Recruiting | Phoenix | Arizona | 85019 | United States |
|
| D009696 | Nucleic Acids |
| D058727 | RNA, Small Untranslated |
| D022661 | RNA, Untranslated |