miRNA in Sepsis
ProceduremiRNA in Sepsis
NCT Number: NCT02055105
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.
Interested in participating?
Request Info1 year–18 year
All sexes
Observational
Phoenix Children's Hospital, Phoenix, Arizona, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
miRNA in Sepsis
Time frame: Duration of hospital stay, an expected average of 3 weeks
Will compare PRISM 3 scores from baseline to hospital discharge.
Time frame: Duration of hospital stay, an expected average of 3 weeks
Will compare sequential organ failure assessment (SOFA) scores throughout hospitalization.
Time frame: Duration of hospital stay, an expected average of 3 weeks
Will compare pediatric multiple organ dysfunction scores (PMODS) throughout hospitalization
Time frame: Duration of hospital stay, an expected average of 3 weeks
Will assess TISS-28 scores throughout hospitalization.
Contact information is provided by the study sponsor or research team.
Althaia Calla G Ignacio, BSN, MD
CONTACT
Frederick A Willyerd, MD
CONTACT
Phoenix Children's Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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