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

NCT ID: NCT04063787

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2022-07-27

Brief Summary

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.

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%.

Conditions

Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fist Assist

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fist Assist Devices, LLC

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Hammes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB19-0306

Identifier Type: -

Identifier Source: org_study_id