跳至主要内容
临床试验/NCT03137680
NCT03137680Unknown不适用

Effect Of Pre-Operative Forearm Exercise On Arteriovenous Fistula Mauration and Blood Flow

Changi General Hospital0 个研究点目标入组 40 人开始时间: 2017年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Hemodynamics in the fistula artery and vein, pre and post AV fistula formation

研究概览

简要总结

To investigate the effect of pre-operative exercise on

  1. Hemodynamics in the fistula artery and vein, pre and post AV fistula formation
  2. Suitability of cannulation of AV fistula at 8weeks

详细描述

Aim: To investigate the effect of pre-operative exercise on hemodynamics in the fistula artery and vein, pre and post AV fistula formation as well as the suitability of cannulation of AV fistula at 8weeks post sugery

Methodology: This is a randomised control study with 20 patients each in the exercise arm and the control arm. The subjects will be randomised 1:1 into one of the two groups. Chronic Kidney failure patients with eGFR less than 20mls/min and have chosen Haemodialysis as their modality of renal replacement therapy will be included the study. All the subjects will have an ultrasound doppler vein mapping done prior to entering the study.

The exercise protocol for the intervention group will be to squeeze a soft ball 10 times for set and perform 3 sets of 10 squeezes each at an 1 minute interval. Three sets of exercises to be performed twice in the morning and twice in the evening, for a total of six weeks.

All patients will have a follow up ultrasound doppler of the AV fistula at 8 weeks and 16 weeks post-surgery, looking at the AV fistula vein diameter, arterial diameter and blood flow rate. All the subjects will also be seen by a single vascular surgeon following the scan, to assess the suitability for AVF cannulation.

Significance of the proposed study and benefits: A well functioning arterio-venous fistula is the gold standard vascular access for Hemodialysis patients due to its low rates of complications. The primary failure rate of the AVFs remain high at around 20 -25%, contributed by several factors including the diameter of the vessels. If pre-operative exercise improves the hemodynamics of the AV fistula and aids the maturation rate in our study, it can be incorporated into clinical guidelines to reduce the primary failure rate of AV fistulas.

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
Single (Care Provider)

盲法说明

Care Provider i.e., vascular surgeon are blinded to subject randomisation

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic Kidney failure patients with eGFR less than 20mls/min
  • Chosen Hemodailysis as their modality of renal replacement therapy

排除标准

  • Potential fistula vein diameter less than 3mm (with application of tornique) on initial vein mapping
  • Known left ventricular ejection fraction of less than 20% on Echocardiogram
  • Previous stroke effecting the AV fistula arm
  • Calcified brachial or radial arteries and/or duplex evidence of stenosis of >50%

结局指标

主要结局

Hemodynamics in the fistula artery and vein, pre and post AV fistula formation

时间窗: 22 weeks

AV fistula vein diameter, arterial diameter and blood flow rate will be assessed and compared

次要结局

  • Suitability of cannulation of AV fistula(8 Weeks)
  • Secondary fistula failure(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sreekanth Koduri

Consultant

Changi General Hospital

相似试验