N/A
Completed N=46
Intermittent Pneumatic Compression Device for Vein Dilation in Kidney Disease Patients to Enable AVF Creation (FACT)
Source: ClinicalTrials.gov NCT04063787 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Vein Diameter — 1.692; 2.100 millimeters — p=0.012
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vein Diameter |
1.692; 2.100 | 0.012 sig |
| SECONDARY AVF Creation |
20; 16; 1 | — |
| SECONDARY AVF Maturation |
24; 12; 1 | — |
| SECONDARY Subsequent Exposure to Central Venous Catheters |
15; 19; 3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04063787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.