Reduction of Microemboli of Air Using a New Developed Air Trap (EmbolessTM) During Haemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of change in air micro bubbles during hemodialysis
研究概览
简要总结
During hemodialysis (HD) the blood of the patient pass an extracorporeal circuit that contains a dialyzer for rinsing and a venous chamber (air trap) to prevent from air embolism through the return blood into the patient. However, air traps in clinical use have limited capacity to prevent from microemboli of air to enter the return bloodline and deposit as emboli in the body such as lungs, heart and brain. The Investigator developed the air trap Emboless that was patented. In vitro studies showed significantly better reduction of microemboli contaminations than air traps compared to that in clinical use.
The present randomized clinical trial compares two different air traps used by the same patients in a cross-over design (as pairs) using the Emboless compared with the Fresenius 4008/5008 (F5008).
Chronic HD patients are randomized to perform the first HD with either their standard air trap (F5008) in the venous bloodline tubing or using the Emboless bloodline and vice versa. Each patient was included to make two paired series. A safety committee evaluates if significantly worse outcome appears especially with the Emboless, to stop the study.
During HD the microbubbles are counted by a GAMPT ultrasound device using two probes. One probe is set at the inlet side of the air trap and the second at the outlet side. The outlet side represents data of microbubbles in the blood that are entering into the patient. Comparative non-parametric paired analyses are performed between the air traps.
Monitoring of the study is performed.
详细描述
During hemodialysis (HD) the blood of the patient pass an extracorporeal circuit that contains a dialyzer for rinsing and a venous chamber (air trap) to prevent from air embolism through the return blood into the patient. However, air traps in clinical use have limited capacity to prevent from microemboli of air to enter the return bloodline and deposit as emboli in the body such as lungs, heart and brain. The Investigator developed the air trap Emboless that was patented in Europe, USA and India. In vitro studies showed significantly better reduction of microemboli contaminations than air traps compared to that in clinical use.
The present randomized clinical trial compares two different air traps used by the same patients in a cross-over design (as pairs) using the Emboless compared with the Fresenius 4008/5008 (F5008).
Chronic HD patients are randomized to perform the first HD with either their standard air trap (F5008) in the venous bloodline tubing or using the Emboless bloodline and vice versa. Each patient is included to make two paired series. A maximum of 30 patients are planned. Each with 2 series of each two different sets of air traps that would give a total of 120 dialyses. A safety committee evaluates if significantly worse outcome appears especially with the Emboless.
During HD the microbubbles are counted by a GAMPT ultrasound device using two probes. One probe is set at the inlet side of the air trap and the second at the outlet side. The outlet side represents data of microbubbles in the blood that are entering into the patient. Comparative non-parametric paired analyses are performed between the air traps.
Monitoring of the study is performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Measuring data of microemboli counts is masked for the patient.
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
- •Accepted are all patients performing chronic HD due to End Stage renal disease of any reason:
- •18 years and older
- •accept, by consent, to participate in the study
- •both genders,
- •any ethnicity
排除标准
- •Patients that are expected not to fulfil a whole series of two dialysis within the study such as those:
- •who suffer from active cancer or severe infection, cachexia or are planned for kidney transplantation close to the study period.
- •patients that by any reason are considered inappropriate by the principal investigator, such as patients that experience severe hypotensive episodes during standard dialysis.
- •Home-haemodialysis treatments and self-care dialysis treatments are not included in the study. If such patient accepts to participate in the study, he/she has to adapt to study criteria (assisted treatment).
结局指标
主要结局
Comparison of change in air micro bubbles during hemodialysis
时间窗: 1 year
Numbers of air micro bubbles (diameter sizes from 20-500µm diameter) are counted at inlet and outlet of the air trap with parallel probes using ultrasound GAMPT 200 device during 30minutes of HD. A calculation clarifies change in percentage of outlet versus inlet amount/size of microbubble air return into the return bloodline that is connected to the return needle placed in the vein of the patient. The size in diameter and numbers within the dialysis time/30 minutes of HD are given.
次要结局
- adverse events(1 year)
- Comparison of change in air micro bubbles for hemodialysis versus hemodiafiltration(1 year)