Colchicine in Postoperative Fontan Patients (CPFP)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
研究概览
简要总结
The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the inflammation in the chest tube drainage after the Fontan operation, and can decrease the amount of time that patients having this surgery will have drainage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 20 months to 5 years and 364 days are eligible
- •Diagnosed with single ventricle heart disease requiring Fontan palliation
- •Undergoing Fontan palliation at the University of Michigan Congenital Heart Center
- •Ability to take oral or enteral medication
排除标准
- •Treatment with another investigational drug within 3 months
- •Pre-existing myelosuppression or decreased bone marrow activity.
- •Current or recent treatment with certain drugs
- •Renal or hepatic impairment deemed by the study team
- •Conditions and/or post-operative complications that would increase risk to the patient such as mechanical support (ECMO) or issues in the intensive care unit (ICU)
研究组 & 干预措施
Colchicine
Colchicine will be given at 0.6 mg once daily for the duration of chest tube output plus 24 hours after chest tube removal with a maximum of 4 weeks duration.
干预措施: Colchicine (Drug)
结局指标
主要结局
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
时间窗: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
Difference is shown via two columns of separate data, but given that enrollment didn't meet target before termination statistical analysis was not done for this measure
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
时间窗: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
Cytokine total mass measured by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay.
次要结局
- Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine(Date of chest tube drainage discontinuation, approximately 11 days after surgery)
- Difference of Duration of Pleural Drainage of Two Groups, in Empiric Treatment With Colchicine Compared to a Cohort of Fontan Patients Not Treated With Colchicine(Date of chest tube drainage discontinuation, approximately 11 days after surgery)
- Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine(Postoperative days 1, 2, 3, 4, 7)
- Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients(Postoperative days 1, 2, 3, 4, 7, 10)
- Difference in Hospital Length of Stay(Hospital discharge at study completion, approximately 2 weeks after surgery)
- Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine(Hospital discharge at study completion, approximately 2 weeks after surgery)
研究者
Stephanie Goldstein
House Officer, Pediatric Cardiology and House Officer, Pediatric Critical Care (during active trial status)
University of Michigan