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临床试验/NCT02055105
NCT02055105招募中不适用

Modulation of Molecular Fingerprinting in Pediatric Sepsis

Phoenix Children's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Risk of Mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Risk of Mortality

时间窗: Duration of hospital stay, an expected average of 3 weeks

Will compare PRISM 3 scores from baseline to hospital discharge.

次要结局

  • Patient acuity(Duration of hospital stay, an expected average of 3 weeks)
  • Organ Failure(Duration of hospital stay, an expected average of 3 weeks)
  • Organ Dysfunction(Duration of hospital stay, an expected average of 3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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