Diagnostic and Prognostic Biomarkers to Elucidate Sepsis Endotypes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- death and chronic critical illness
研究概览
简要总结
Determine the utility of biomarkers measured in blood and body fluid (stool, saliva, tracheal aspirate) when combined with clinical data, for predicting sepsis phenotypes that are associated with poor clinical outcomes. We hypothesize that resistin is a biomarker which provides critical prognostic information when used in conjunction with standard clinical data, in patients with sepsis and septic shock.
详细描述
Day 1 Sample Collection: 20ml of blood for chemical and genetic biomarker analysis. ≤1ml of saliva, stool, and tracheal aspirate for inflammatory marker analysis. Quadratus lumborum muscle size measurement and CT abdomen correlation. If not part of routine care, additional blood tests for cell differential, procalcitonin, and inflammatory markers.
Electronic Medical Records (EMR) Data: APACHE II and SOFA severity scores. Demographics, vital signs, inflammatory markers, organ dysfunction markers, and various blood chemistry values.
Days 2-3 Daily Documentation: Record the most abnormal value for the same parameters as Day 1.
Days 3-5 (Once) Sample Collection: Repeat of blood, saliva, stool, and tracheal aspirate collection. EMR data access for severity scores and other clinical parameters.
Days 5-6 Daily Documentation: Continued recording of the most abnormal values for clinical parameters.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age ≥ 18 )
- •gender: male or female
- •Cognitively intact or impaired patients, given that sepsis may cause a certain degree of cognitive dysfunction in patients. All patients in the control group (no sepsis) will be cognitively intact
- •Clinical suspicion for sepsis (except for control/comparison group for whom infection is NOT a current concern)
排除标准
- •Patients with hematologic malignancies
- •Pregnant women
- •Patient/surrogate is not fluent in English and no translation services are available
- •Long-term immunosuppressive therapy
结局指标
主要结局
death and chronic critical illness
时间窗: 5 years for completion of study, 1 year follow up per patient enrolled
The primary outcome is a composite binary variable consisting of early death and chronic critical illness which we will determine on or before day 14 after sepsis onset.
次要结局
- Sequential Organ Failure Assessment(5 years for completion of study, 1 year follow up per patient enrolled)
- The expression of BPGM and AP2 transcripts(5 years for completion of study, 1 year follow up per patient enrolled)
- Muscle measurements(5 years for completion of study, 1 year follow up per patient enrolled)
- Clinical variables(5 years for completion of study, 1 year follow up per patient enrolled)
- Acute Physiology and Chronic Health Evaluation II Score(5 years for completion of study, 1 year follow up per patient enrolled)
研究者
Anthony Bonavia
Professor
Penn State Health Milton S Hershey Medical Center