Second Generation Surveillance Techniques to Prevent Thrombosis and Increase Assisted Primary Patency in Native Arteriovenous Fistula. A Prospective Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 5
- 主要终点
- Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method
研究概览
简要总结
All vascular access guidelines recommend monitoring and surveillance protocols to prevent vascular access complications in hemodialysis units.
However, in the case of second generation screening techniques which determine access blood flow measurement (QA), there is a huge controversy about it´s efficiency.
Although multiple observational studies find a decrease in the thrombosis rate and an increased primary assisted patency survival related to the use of these techniques, a recently published meta-analysis find contradictory results in the randomized controlled trials, affirming that the measurement of QA is useless in grafts and questionable in native arteriovenous fistulae (AVF).
We have designed a multicenter, prospective, open label, controlled, randomized trial, to prove the usefulness of the QA measurement using two complementary second generation techniques, Doppler ultrasound and Transonic dilution method, compared to the classical monitoring and surveillance methods.
The primary endpoint will be a reduction in the thrombosis rate with an increased assisted primary patency survival, and a cost effectiveness economic analysis.
As secondary endpoints we will analyze the impact over non-assisted primary patency survival and secondary patency survival.
详细描述
Definition:
Multicenter, prospective, open label, controlled, randomized trial, to prove the usefulness of the QA measurement using two complementary second generation techniques, Doppler ultrasound and Transonic dilution method, compared to the classical monitoring and surveillance methods.
For Patient Registries:
Clinical data repository (CDR) paper notebook will contain all baseline patient characteristics and the information related to vascular access. These data will be collected by the different investigators and reviewed and included in data base by the study´s monitor.
This information will be included in a centralized computer database (SPSS 15.0 computer system) and encoded in order to preserve patients´ confidentiality.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signature.
- •Age between 18 and 95 years old.
- •Functioning native AVF.
- •Patients with end stage renal disease (ESRD) undergoing hemodialysis program for at least three months.
排除标准
- •Coagulopathy or hemoglobinopathy of any cause.
- •Hospitalization of any cause in the previous month.
- •VA related complications or dysfunction in the previous three months.
研究组 & 干预措施
Clasical Surveillance of AVF
Classical evaluation of AVF includes:
- Vital sings and predialysis physical examination of AVF every dialysis session.
- Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session.
- Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation.
- Quarterly recirculation with urea method.
Following Spanish Nephrology VA guidelines will be consider as alarm criteria:
1.25% Increased venous pressure. 2.25% Decreased pump blood flow. 3.0,2 ktv decreased compared with previous measurement. 4.> 10% recirculation using urea method. 5.Prolonged coagulation time or cannulation difficulties in 3 consecutive dialysis sessions.
6.Pathologic physical examination with any other criteria.
干预措施: vital signs (Procedure)
Clasical Surveillance of AVF
Classical evaluation of AVF includes:
- Vital sings and predialysis physical examination of AVF every dialysis session.
- Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session.
- Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation.
- Quarterly recirculation with urea method.
Following Spanish Nephrology VA guidelines will be consider as alarm criteria:
1.25% Increased venous pressure. 2.25% Decreased pump blood flow. 3.0,2 ktv decreased compared with previous measurement. 4.> 10% recirculation using urea method. 5.Prolonged coagulation time or cannulation difficulties in 3 consecutive dialysis sessions.
6.Pathologic physical examination with any other criteria.
干预措施: physical examination of AVF (Procedure)
Clasical Surveillance of AVF
Classical evaluation of AVF includes:
- Vital sings and predialysis physical examination of AVF every dialysis session.
- Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session.
- Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation.
- Quarterly recirculation with urea method.
Following Spanish Nephrology VA guidelines will be consider as alarm criteria:
1.25% Increased venous pressure. 2.25% Decreased pump blood flow. 3.0,2 ktv decreased compared with previous measurement. 4.> 10% recirculation using urea method. 5.Prolonged coagulation time or cannulation difficulties in 3 consecutive dialysis sessions.
6.Pathologic physical examination with any other criteria.
干预措施: ktv test (Procedure)
Clasical Surveillance of AVF
Classical evaluation of AVF includes:
- Vital sings and predialysis physical examination of AVF every dialysis session.
- Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session.
- Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation.
- Quarterly recirculation with urea method.
Following Spanish Nephrology VA guidelines will be consider as alarm criteria:
1.25% Increased venous pressure. 2.25% Decreased pump blood flow. 3.0,2 ktv decreased compared with previous measurement. 4.> 10% recirculation using urea method. 5.Prolonged coagulation time or cannulation difficulties in 3 consecutive dialysis sessions.
6.Pathologic physical examination with any other criteria.
干预措施: urea method (Procedure)
Second generation surveillance of AVF
In addition to the classical surveillance and monitoring methods, in the experimental group Doppler ultrasound and transonic dilution method will be performed on a quarterly basis.
In addition to the classical alarm criteria and derived from the results in Doppler ultrasound an transonic dilution method the following alarm criteria would also be considered in the experimental group:
- 25% or higher decreased in QA compared with previous measurement.
- QA lower than 500 ml/min.
- Stenotic area with a higher than 50% reduction of blood vessel lumen would be considered as alarm criteria only if it comes with a haemodynamic repercussion criteria defined as Peak systolic velocity (PSV) higher than 400 cm/sc, aliasing, or PSV ratio stenosis/pre-stenosis higher than 3.
干预措施: Second generation surveillance of AVF (Device)
Second generation surveillance of AVF
In addition to the classical surveillance and monitoring methods, in the experimental group Doppler ultrasound and transonic dilution method will be performed on a quarterly basis.
In addition to the classical alarm criteria and derived from the results in Doppler ultrasound an transonic dilution method the following alarm criteria would also be considered in the experimental group:
- 25% or higher decreased in QA compared with previous measurement.
- QA lower than 500 ml/min.
- Stenotic area with a higher than 50% reduction of blood vessel lumen would be considered as alarm criteria only if it comes with a haemodynamic repercussion criteria defined as Peak systolic velocity (PSV) higher than 400 cm/sc, aliasing, or PSV ratio stenosis/pre-stenosis higher than 3.
干预措施: vital signs (Procedure)
Second generation surveillance of AVF
In addition to the classical surveillance and monitoring methods, in the experimental group Doppler ultrasound and transonic dilution method will be performed on a quarterly basis.
In addition to the classical alarm criteria and derived from the results in Doppler ultrasound an transonic dilution method the following alarm criteria would also be considered in the experimental group:
- 25% or higher decreased in QA compared with previous measurement.
- QA lower than 500 ml/min.
- Stenotic area with a higher than 50% reduction of blood vessel lumen would be considered as alarm criteria only if it comes with a haemodynamic repercussion criteria defined as Peak systolic velocity (PSV) higher than 400 cm/sc, aliasing, or PSV ratio stenosis/pre-stenosis higher than 3.
干预措施: physical examination of AVF (Procedure)
Second generation surveillance of AVF
In addition to the classical surveillance and monitoring methods, in the experimental group Doppler ultrasound and transonic dilution method will be performed on a quarterly basis.
In addition to the classical alarm criteria and derived from the results in Doppler ultrasound an transonic dilution method the following alarm criteria would also be considered in the experimental group:
- 25% or higher decreased in QA compared with previous measurement.
- QA lower than 500 ml/min.
- Stenotic area with a higher than 50% reduction of blood vessel lumen would be considered as alarm criteria only if it comes with a haemodynamic repercussion criteria defined as Peak systolic velocity (PSV) higher than 400 cm/sc, aliasing, or PSV ratio stenosis/pre-stenosis higher than 3.
干预措施: ktv test (Procedure)
Second generation surveillance of AVF
In addition to the classical surveillance and monitoring methods, in the experimental group Doppler ultrasound and transonic dilution method will be performed on a quarterly basis.
In addition to the classical alarm criteria and derived from the results in Doppler ultrasound an transonic dilution method the following alarm criteria would also be considered in the experimental group:
- 25% or higher decreased in QA compared with previous measurement.
- QA lower than 500 ml/min.
- Stenotic area with a higher than 50% reduction of blood vessel lumen would be considered as alarm criteria only if it comes with a haemodynamic repercussion criteria defined as Peak systolic velocity (PSV) higher than 400 cm/sc, aliasing, or PSV ratio stenosis/pre-stenosis higher than 3.
干预措施: urea method (Procedure)
结局指标
主要结局
Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method
时间窗: Up to 3 years follow up
Differences in assisted primary patency rates (thrombosis free access survival) in AVF between the two groups: control group in which classical monitoring and surveillance techniques are applied and experimental group in which Doppler ultrasound and transonic were performed every three months in addition to classical methods. Cost efficacy analysis in both groups will be done, measuring all vascular access (VA) related health care spending (VA hospitalization costs, central venous catheter (CVC) placements, surgeries and endovascular procedures will be recorded).
次要结局
- Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.(Up to 3 years follow up)
- Possible influence of different baseline items in the risk of thrombosis of native AVF(Up to 3 years follow up)
- Reproducibility in Doppler ultrasound technique(Up to 3 years follow up.)
- Evaluate the efficacy and efficiency of second generation methods(Up to 3 years follow up)
- Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.(Up to 1 year follow up)
- Evaluate the efficacy and efficiency of second generation methods(Up to 2 years follow up)
- Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.(Up to 2 years follow up)
研究者
Antonio Cirugeda
Principal Investigator
Hospital Infanta Sofia