Tunneled Femoral Catheter Versus Femoro-femoral Arteriovenous Graft as a Lower-Extremity Hemodialysis Vascular Access: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Primary patency
研究概览
简要总结
This study will compare the outcomes of tunneled femoral catheter and femoro-femoral arteriovenous graft as a bailout procedure for hemodialysis in chronic kidney disease patients with exhausted upper-extremity and chest-wall vascular accesses regarding survival rate, complications, and quality of life
详细描述
Aim of the Work:
The aim of this work is to compare the outcomes of tunneled femoral catheter (TFC) and femoro-femoral AVG as regards survival, complication and quality of life as bailout procedure for hemodialysis in CRF patient with exhausted upper limb extremity and chest wall vascular accesses.
Patients and Methods:
Study Design and setting:
This is a single-centre prospective randomized controlled trial that will be conducted in The Vascular Surgery Department, Mansoura University Hospital, during the period from November 2020 to November 2022. It will be submitted for approval by Institutional Review Board, faculty of medicine, Mansoura University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All end-stage renal disease patients who complain of exhaustion of all upper-extremity and chest-wall vascular accesses.
- •≥ 15 years
排除标准
- •patients with previous history or evident deep venous thrombosis
- •varicose veins
- •femoral vein stenosis
- •arterial insufficiency
- •severe groin or limb infection.
结局指标
主要结局
Primary patency
时间窗: 12 months postoperatively
In case of TFC: Normally an extracorporeal blood flow should be about 300 ml/min. based on this, the catheter dysfunction can be defined by the first occurrence of either (1) peak blood flow of 200 ml per minute or less for 30 minutes during a dialysis treatment, (2) mean blood flow of 250 ml per minute or less during two consecutive dialysis treatments, or (3) inability to initiate dialysis owing to inadequate blood flow, after attempts to restore patency have been attempted. - In case of AVG, stenosis \> 50% of the prosthesis diameter or complete occlusion is considered significant. This can be assessed by duplex ultrasonography every six months or when the patency is questionable. The patency rates will be determined according to the reporting standards, set by the Committee of Reporting Standards for arteriovenous hemodialysis accesses.
次要结局
- Secondary patency(24 months)
- Special adverse events complicating lower-extremity haemodialysis access(24 months)
- Patient satisfaction(6 & 12 months postoperatively)
研究者
Mohammed Mosallam Mohammed Ibrahim
Specialist of Vascular Surgery, MD candidate
Mansoura University