Intermittent Pneumatic Compression Device for Vein Dilation in Kidney Disease Patients to Enable AVF Creation (FACT) (FACT)

Use of an Intermittent Pneumatic Compression Device to Promote Vein Dilation in Patients With Kidney Disease to Enable Creation of Arteriovenous Fistulas

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.

Study Overview

• Status: Completed
• Conditions: Kidney Diseases
• Intervention / Treatment: Device: Fist Assist

Detailed Description

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.

Protocol: Informed consent will be obtained by the co-investigators using a written consent form approved by the Institutional Review Board. After informed consent is obtained, patients will receive: physical examination of both forearms; and a vascular Doppler to determine cephalic vein diameters of the nondominant arm. A 10 mL blood sample will be drawn at the next routine phlebotomy.

Patients will be asked to apply the Fist Assist® to the upper half of the non-dominant arm. Patients will be asked to use the device twice daily for two 2-hour periods, and report any complications or problems, using a log (see log attached at end of References). Patients will have follow up examinations with measurement of cephalic vein diameter at three months after enrollment.

DURATION OF STUDY: All subjects will be enrolled and treated for three months. The duration of the study including data analysis and statistical analysis is expected to be 12 months.

STATISTICAL ANALYSES: The primary outcome of interest will be the difference in the diameter of the cephalic vein between baseline (Pre) and 3 months (Post) in patients treated with the Fist Assist® device. Based on prior work, mean vein diameters at baseline are anticipated to be approximately 1.8 mm with a standard deviation of 0.5 mm,44 and investigators anticipate that the standard deviation of the change in diameter is likely to be approximately 0.75 mm.

Effect =[(DSPost)-(DSPre)]

Investigators would consider calculated effect sizes of 0.25-1.0 mm to be clinically meaningful changes that would increase the numbers of patients with vein diameters that meet commonly accepted thresholds for surgical suitability (normally 2.5-3.0 mm). Sample size calculations for a variety of effects are presented in table 1 (below), based on paired t-tests with alpha error of 0.05, standard deviation of the effect size of 0.75 mm, for power of 80% and 90%.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fist Assist device (all subjects); All study subjects will have Stage 4 or 5 Chronic Kidney Disease (CKD) that requires them to start hemodialysis. In preparation for hemodialysis, they will have an arteriovenous fistula (AVF) procedure which provides access to the veins for dialysis. This study is testing a device called the Fist Assist to dilate the vein in preparation for dialysis. The device is similar to a blood pressure cuff (worn around the arm and applies pressure). All study participants will wear the Fist Assist twice a day up to three months before their AVF procedure.

Device: Fist Assist; The Fist Assist device works by applying pressure to the subject's arm in the area where their arteriovenous fistula will eventually be created. The device is mobile and battery powered. 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. They will be asked to do this for 3 months, and will come in to be evaluated via study visits at Months 3, 6, 9 and 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vein Diameter	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AVF Creation	Whether or not an arteriovenous fistula was created, as defined by a procedure performed by surgery or interventional radiology connecting an artery to a vein.	12 months
AVF Maturation	Whether the resultant AVF matured, as defined successful cannulation with two needles for three hemodialysis treatments.	12 months
Subsequent Exposure to Central Venous Catheters	The subject's subsequent exposure of patients to central venous catheters during their first year for hemodialysis. We measured the total number of patients who had exposed to central venous catheters over the first year.	12 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Fist Assist Devices, LLC
• Investigators: Principal Investigator: Mary Hammes, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): July 27, 2022

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases
• Other Study ID Numbers: IRB19-0306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes