Effect of Far Infrared Therapy on Arteriovenous Fistulas Maturation, Survival and Stenosis. A Randomized, Controlled Open-labeled Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 10
- 主要终点
- Time to fistula maturation for the incident fistulae
研究概览
简要总结
The number of hemodialysis patients in the world are increasing. In order to receive a sufficient dialysis, the patients needs a well functioning and stable vascular access - preferably an arteriovenous fistula (AVF). Unfortunately, the AVF has a high incidence of stenosis with percutaneous trans luminal angioplasty (PTA) as the only treatment option and a short lifetime. Little do we know of how to improve the survival of the AVF.
With this study we want to explore the effect of far infrared therapy on the stenosis, maturation and survival of the arteriovenous fistula.
The investigators will divide the patients into 2 groups: A treatment group and a control group.
The treatment group will receive infrared therapy on their fistula during their dialysis session. The control group will not receive any infrared therapy.
The investigators hope to reduce the risk of stenosis in the fistula and improve the fistula survival with this treatment.
Furthermore, the investigators want to explore the change in several biochemical markers during the treatment with infrared therapy.
详细描述
Background:
The number of hemodialysis patients in the world are increasing. In order to receive an efficient dialysis, the patient needs a well-functioning and stable vascular access. Presently there is three options: an arteriovenous fistula (AVF), an arteriovenous graft (AVG) and a central venous catheter (CVC). CVCs are associated with an increased risk of stenosis of the central vessels, thrombosis in the AVF, infections and death. AVGs are associated with increased risk of infections, stenosis in the AVG and loss of access. This is why, the AVF is the preferred vascular access. But this vascular access does not come without risks. After the creation of an AVF there is a risk of 50 % for never maturing, which means the AVF cannot be used. Furthermore, the risk of stenosis in the AVF is also high, up to 67 % of the AVFs will have a stenosis, that needs an intervention. During this time the patient needs an alternative vascular access, such as a central venous catheter, which is related to an increased risk of infection, more hospital days and death.
The maturation of the AVF depends on several patient related, but also surgically related factors. Factors such as comorbidity, female sex, length of end stage renal disease, anatomy of the vessel, surveillance after AVF placement and the operations itself have all been shown to affect the AVF maturation. Fistula stenosis emerges from an endothelial dysfunction, inflammation and smooth muscle cell proliferation leading to intimal hyperplasia and in the end stenosis. Factors such as increased blood flow, inflammation, uremia and percutaneous transluminal angioplasty has been shown to affect the stenosis, It is not well understood, which molecular mechanism are responsible for the intimal hyperplasia.
There are few and not well established studies on how to improve the AVF survival and maturation.
Far infrared radiation (FIR) is an electromagnetic radiation (heat therapy), that is given directly on the skin above the AVF. In a few single center studies in Taiwan it has been shown to decrease the risk of stenosis and increase the fistula survival and maturation. However another study is disputing this. The mechanism behind FIR and better fistula survival is not fully understood. The infrared light is supposed to have a thermal effect, which leads to vasodilatation and a non-thermal effect, which influence the endothelial function and vasodilation and thereby it may decrease the inflammation and proliferation in the fistula, primarily through the releasing of several anti-inflammatory and vasodilating factors. This is not well documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •For incident AVF:
- •Patients of 18 years of age or above
- •Patients on chronic hemodialysis with a central venous catheter, who is having an AVF placed
- •An AVF, that are maximum 3 weeks old
- •For prevalent AVF:
- •Patients in chronic hemodialysis with a functioning AVF
- •Patients of 18 yeas of age or above
排除标准
- •Not obtainable informed consent
- •Non compliant patients
- •Patients who use both a CVC and an AVF as their vascular access
- •Patient on both hemodialysis and peritoneal dialysis
- •Planned living donor kidney transplantation
- •Short life expectancy, less than a 1 year
- •Patients on hemodialysis less than 3 times per week
结局指标
主要结局
Time to fistula maturation for the incident fistulae
时间窗: After 12 months
Time from placement of the fistula to successful cannulation with 2 needles and successful hemodialysis treatment
Difference in number of fistula intervention for the prevalent fistulae
时间窗: After 12 months
For the fistulae with or without previous interventions we expect to find a decrease in the number of interventions in the treatment group compared to the control group
次要结局
- The incidence of primary patency in the incident group(After 12 months)
- Baseline value in serum amyloid A as a predictor for AVF survival and stenosis(After 12 months)
- Difference in number of fistula interventions in the incident fistula group(After 12 months)
- Difference in the fistula diameter in the incident fistula group(After 12 months)
- Number of patients with a never functioning fistula in the incident group(After 12 months)
- Baseline in nitrite and nitrate as a predictor for AVF survival stenosis(After 12 months)
- Number of abandoned fistulae in incident and prevalent groups(After 12 months)
- Baseline value in von willebrand factor as a predictor for AVF survival stenosis(After 12 months)
- Baseline in different biomarkers as a predictor for AVF survival stenosis(After 12 months)
- Change in access flow in the incident and prevalent group(After 12 moths)
- Baseline value in adhesion molecules, heme-oxygenase and ADMA and selectin as a predictor for AVF survival stenosis(After 12 months)
研究者
Kristine Lindhard
Principal Investigator
Herlev and Gentofte Hospital
