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临床试验/NCT03213756
NCT03213756已完成不适用

Effect of Isometric Preoperative Exercise on Vascular Caliber and the Maturation of Autologous Arteriovenous Fistulas. Randomized Clinical Trial

Hospital General Universitario Gregorio Marañon2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2017年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
2
主要终点
Impact of PIE on AVF primary failure comparing the control group and the PIE group.

研究概览

简要总结

A good vascular access (VA) is vital for hemodialysis (HD) patients. The start of HD with autologous arteriovenous fistula (AVF) means higher survival, lower sanitary costs and complications. The distal forearm AVF is known as the best option but not all patients are good candidates for this surgery, and there is a primary failure rate between 20 and 50% published in literature.

The choice of the optimal AVF for each patient is conditioned mainly by the anatomical and hemodynamic characteristics of the artery and the vein chosen to perform the anastomosis. These characteristics can be modified by performing physical exercise Some vascular access guidelines suggest the performance of isometric exercises in the pre and postoperative period of the AVF confection. However, there is very little data in literature on the possible efficacy of preoperative exercise, although small published observational studies point to an improvement in the venous and arterial caliber. Regarding the postoperative exercises, they do seem to improve maturation, however the degree of evidence in literature is low and there is no consensus on the exercise protocol to follow.

We present an open-label, multicenter, prospective, controlled and randomized study in order to evaluate the usefulness of preoperative isometric exercise (PIE) in pre-dialysis patients or in prevalent HD with indication of performing a new AVF. The randomization will be 1: 1, one group of patients will perform PIE for 8 weeks and the other group of patients will be a control group. The main purpose will be to evaluate if there is a lower rate of primary failure in the PIE group compared with control group.

详细描述

RECRUITING PERIOD: 20 months.

FOLLOW UP: From the first preoperative assessment visit for AVF up to 3 months after its creation.

METHODS:

After signing the informed consent, patients will be randomized through a centralized computer program to one of two groups of patients, PIE group versus control group.

In both groups of patients, a first physical examination of upper arm extremities and an initial doppler ultrasound will be performed, evaluating the anatomical and hemodynamic characteristics of the arteries and veins of both arms. At that time, a first surgical option of AVF will be indicated.

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

入选标准

  • Informed consent signature.
  • Age between 18 and 89 years.
  • Patients with advanced chronic kidney disease, stages IV-V, in pre-dialysis or prevalent HD patients, requiring new AVF.

排除标准

  • Absence of adequate arteries and veins to allow autologous AVF. (The minimum gauges that will be considered in order to perform an autologous AVF are: artery caliber equal or greater than 1.6 mm and vein caliber equal or greater than 1,8 mm with a compressor).
  • Diagnosis of coagulopathy or hemoglobinopathy of any cause.
  • Patients who urgently need an AVF without the possibility of being 8 weeks on the surgical waiting list.
  • Impossibility to perform the physical exercise protocol due to physical or mental disabilities or lack of social support.

结局指标

主要结局

Impact of PIE on AVF primary failure comparing the control group and the PIE group.

时间窗: 12 weeks after AVF surgery (visit 6)

We will evaluate in both groups the primary failure rate. It will be evaluated during visit 6 (12 weeks after AVF creation). We expect a lower primary failure rate in the PIE group.

次要结局

  • Differences on the caliber of upper arm arteries and veins in the PIE group before and after isometric exercise.(8 weeks follow up visit before surgery (visit 3))
  • Impact of AVF evaluation with doppler ultrasound in the postoperative period in both groups, adding the usual isometric exercise with ball contraction in all patients.(12 weeks after AVF surgery (visit 6))
  • Analysis of the optimal arterial and venous calibres to minimize the primary failure of AVF according to the individual risk factors in both groups of patients.(12 weeks after AVF surgery (visit 6))
  • Percentage of candidate patients for autologous distal or proximal AVF in both groups.(1 week after AVF surgery (visit 4))
  • Impact of nutritional-inflammatory status on AVF outcomes(12 weeks after AVF surgery (visit 6))

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ines Aragoncillo

Nephrologist

Hospital General Universitario Gregorio Marañon

研究点 (2)

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