Do Changes in Serum Hepcidin-25 Concentration Predict Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment Responses?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Serum Hepcidin-25 Concentration After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment
研究概览
简要总结
The goal of this study is to identify chemical compounds in the blood and sputum (i.e., biomarkers) that are associated with objective measurements of health status in patients with cystic fibrosis (CF). This study builds upon observations that blood levels of hepcidin-25, a protein that regulates how the body uses and stores iron, vary during CF pulmonary exacerbation (CFPE).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Women who are pregnant or lactating;
- •Subject does not meet Inclusion criteria;
- •Recent and/or persistent visible blood in sputum (hemoptysis);
- •Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use for health deterioration rather than chronic suppression
结局指标
主要结局
Change in Serum Hepcidin-25 Concentration After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment
时间窗: Duration of hospitalization, an expected average of 12 days
The primary endpoint of this study is the characterization of 3 groups (i.e., "low," "intermediate," and "high") of serum hepcidin-25 responders to CFPE treatment. Response will be defined as the ratio of post- to pre-treatment serum hepcidin-25 concentration for each subject.
次要结局
- Change in Serum Iron After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in Serum Interleukin-6 (IL-6) Concentration After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in Sputum Iron Content After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in Percent-Predicted Forced Expiratory Volume in One Second (FEV1%) After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in Body Mass Index (BMI) After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in Hemoglobin Concentration After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in CFRSD-CRISS Score After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in Serum EPO Concentration After Hospitalization for CF Pulmonary Exacerbation (CFPE) Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in Transferrin Saturation After Hospitalization for CF Pulmonary Exacerbation Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in Serum TREM-1 Concentration After Hospitalization for CF Pulmonary Exacerbation Treatment(Duration of hospitalization, an expected average of 12 days)
- Change in Serum sIL-6R Concentration After Hospitalization for CF Pulmonary Exacerbation Treatment(Duration of hospitalization, an expected average of 12 days)
研究者
Alex H. Gifford
Associate Professor of Medicine
Dartmouth-Hitchcock Medical Center