Use of an Intermittent Pneumatic Compression Device to Promote Vein Dilation in Patients With Kidney Disease to Enable Creation of Arteriovenous Fistulas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Vein Diameter
研究概览
简要总结
This is a single center pilot study that is seeking to determine whether the use of the Fist Assist® device for 360 hours over 90 days by patients with advanced CKD prior to AVF surgery results in significant increases in cephalic vein diameters prior to AVF surgery.
详细描述
METHODOLOGY:
Intervention: The Fist Assist® device will be assigned to each enrolled subject by randomization code. All subjects will be asked to use their assigned device twice daily, for two 2-hour sessions, once in the morning and once in the evening. Patients will apply the device to the non-dominant arm above the level of the elbow, and to keep a written log to record use, complications and any problems.
Blood Draws: 10 mL of blood will be obtained from patients being enrolled at the time of their next routine standard of care phlebotomy. These samples will be frozen for future assays of endothelial biomarkers of nitric oxide production and venous dilation, such as asymmetric dimethyl arginine (ADMA) and its metabolites.
Doppler: Patients will undergo examination of their cephalic veins in the Nephrology Clinic, using a portable vascular ultrasound device operated by a co-investigator trained by the University of Chicago Medical Center Vascular Lab in this technique. The cephalic vein, a superficial vein originating in the wrist, is the most common vein used for AVF creation. In order to standardize these measurements, the diameter of the cephalic vein and vein wall thickness will be measured in both arms at: (a) 5 cm proximal to the styloid process of the radius, and (b) at the antecubital fossa. The diameter and thickness of the vein will be measured using a B-mode image acquired using a standard ultrasound machine with vascular probe going from outer walls per protocol. Patients will be seated with arms supported at the level of the heart on an exam table with in a room with a temperature of at least 20 degrees Celsius. A layer of at least 1 cm of gel will be applied locally to optimize the ultrasound image quality. Vascular Doppler measurements will be obtained on both arms at the time of consent (baseline), and at the conclusion of therapy. Measurements will be recorded.
Follow Up: Those who are subsequently able to undergo successful AVF creation will be followed clinically for up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •18 and older
- •Followed in the University of Chicago Medical Center's Nephrology Clinic
- •Expected to initiate hemodialysis
- •Estimated Glomerular Filtration Rate (eGFR) <30 mL/min.1.73m
- •Exclusion criteria:
- •Refusal/inability to give informed consent
- •Inability to comply with trial requirements,
- •Arm infections and/or skin disorders that require frequent medical attention.
- •Patients with obvious scarring from IV drug use
- •Previous phlebitis.
- •Previous occluded arteriovenous grafts or fistulae
- •Arterial aneurysms
- •Arm deep vein thrombosis
- •Any previous vascular surgery on the non-dominant arm.
- •Limited cognitive ability
- •Motor or sensory deficits in the upper arm
- •Upon preliminary evaluation of the cephalic vein (measured 5 cm proximal to the styloid process of the radius, and at the antecubital fossa) there are no detectable superficial veins of at least 1.0 mm diameter, or superficial vein of more than 3.0 mm is present in this lower arm location.
排除标准
- 未提供
结局指标
主要结局
Vein Diameter
时间窗: 3 months
The primary outcome will be the difference in the vein diameter measured in millimeters with use of a vascular ultrasound device before and after Fist Assist use. The standard deviation of the change in vein diameter will be approximately 0.75mm.
次要结局
- Subsequent Exposure to Central Venous Catheters(12 months)
- AVF Creation(12 months)
- AVF Maturation(12 months)