A Post-Market Clinical Performance and Safety Evaluation of GamCath HighFlow Dolphin Protect Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Reason(s) for Catheter Removal
研究概览
简要总结
The goal of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter in patients with acute kidney injury, acute renal failure, or chronic kidney disease.
The main questions to answer are:
- Duration of catheter use (survival)
- Reason(s) for catheter removal
详细描述
The objective of this retrospective chart review is to obtain clinical safety and performance data for the GamCath HighFlow Dolphin Protect Catheter related to the duration of use (catheter survival) throughout its lifetime.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients ≥ 18 years of age at the time of catheter insertion.
- •Patients diagnosed with AKI, ARF, and/or CKD (including end-stage renal disease [ESRD]).
- •Patients who required vascular access to perform extracorporeal blood purification using GamCath HighFlow Dolphin Protect Catheter inserted by a physician in the subclavian, jugular, or femoral veins.
排除标准
- •Patients who required the GamCath HighFlow Dolphin Protect Catheter for any indication other than extracorporeal blood purification.
- •Patients who had a local infection at the vascular access site prior to catheter insertion.
- •Patients who required surgical intervention (e.g., cutdown procedure) for GamCath HighFlow Dolphin Protect Catheter placement.
- •Patients who had a prior catheter in place at the same vascular access site (i.e., R/L jugular vein, R/L femoral vein, R/L subclavian vein) within the last 7 days.
- •Patients who do not have complete patient records to support the primary endpoint analyses.
结局指标
主要结局
Reason(s) for Catheter Removal
时间窗: Within 72 hours of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks
Collect additional real-world use data describing the reason(s) for GamCath HighFlow Dolphin Protect Catheter removal to support PMCF ongoing product safety performance
Catheter Survival
时间窗: From date of catheter insertion until the date of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks
Confirm catheter lifetime related to GamCath HighFlow Dolphin Protect Catheter duration of use to support PMCF ongoing performance data
次要结局
- Adverse Events(From date of catheter insertion until the date of catheter removal or patient transfer or discharge or death, whichever occurs first, assessed up to 12 weeks)