Clinical Research Directory

Low-Dose Apixaban Added to Standard Heparin Lock Versus Heparin Lock Alone to Prevent Tunneled Hemodialysis Catheters Dysfunction (APICATH-HD)

This randomized, single-center, PROBE trial evaluates whether adding low-dose apixaban (2.5 mg orally every 12 hours) to standard intraluminal heparin lock prolongs primary functional patency of tunneled hemodialysis catheters compared with standard heparin lock alone. Adult patients on hemodialysis with a recently implanted, functioning tunneled catheter (≥8 days) will be randomized 1:1 and followed up to 24 months (or until catheter loss). Primary outcome is time to first intervention for catheter dysfunction or definitive catheter loss. Secondary outcomes include primary-assisted and secondary patency, thrombotic dysfunction, rescue procedures, catheter-related infection, bleeding (ISTH), and mortality. Outcomes adjudication will be blinded.

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.

PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis

The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.

Evaluating the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients

The goal of this clinical trial is to evaluate whether the Valsalva maneuver reduces invasive pain during arteriovenous fistula (AVF) cannulation in adult hemodialysis patients. The main questions it aims to answer are: Does the Valsalva maneuver effectively reduce pain intensity during AVF cannulation as measured by the Visual Analogue Scale (VAS)? Is the Valsalva maneuver feasible, acceptable, and satisfactory for patients, and can it be sustainably implemented over multiple sessions? Researchers will compare patients performing the Valsalva maneuver (intervention group) with those receiving standard care without any intervention (control group) to see if pain scores are significantly lower and whether patients are willing to continue using this technique voluntarily. Participants will: Receive training and supervised practice on the Valsalva maneuver before inclusion in the study Perform the Valsalva maneuver during AVF cannulation in each hemodialysis session for 12 sessions Complete VAS pain assessments after each session Complete a patient satisfaction and feasibility form at the end of the study

Optimizing Access Surgery In Senior Hemodialysis Patients

The number of elderly hemodialysis patients is growing. Vascular access complications are a major determinant of the quality of life and health care costs for these vulnerable patients. The three different types of vascular access, i.e. autologous arteriovenous fistulas, arteriovenous grafts, and central venous catheters, have never been compared in randomized controlled trials. This project will deliver the much-needed evidence to determine the optimal strategy for vascular access creation in elderly hemodialysis patients in order to deliver better health care at lower costs.

Skill Building Education of Arteriovenous-Fistula Self-Care Behaviors and Quality of Life of Patients on Hemodialysis

The purpose of this study is to assess the effectiveness of skill building educational interventions in improving the self-care behaviors and quality of life of AVF in hemodialysis patients. This study will address questions. What is the effect of skill building education on the self-care behaviors of AVF care and quality of life in patients in patients undergoing hemodialysis treatment? A total 274 participants will be recruited from dialysis units of the study hospitals. Using random allocation 137 participants will be assigned to the control group and 137 to the intervention group. The intervention group will additionally receive a skill building education for improving their self-care behaviors and quality of life of AVF. Researcher will implement skill building educational intervention in interventional group to enhance the self-care behaviors and quality of life. This intervention have two session, first is theoretical and another one is practical. The primary outcome of this study is AVF self-care behaviors and secondary outcome is quality of life related to AVF. This outcome will be assessed using the Self-care Behaviors Scale with Arteriovenous Fistula in Hemodialysis patients (ASBHD-AVF). The secondary outcome will be assessed using the Hemodialysis Access-related Quality of Life (HARQ) which is a self-administered tool develop by Nordyke. The primary and secondary outcomes will be assessed at: baseline, after the completion of the intervention, and follow-up data will be collected at the second and sixth weeks after intervention is completed. Data will be analyzed using the Statistical Package of Social Science (SPSS) version 25. Descriptive statistics, means and standard deviations will be used for the continuous variables, while frequencies and percentages will be utilized for categorical demographic data (gender, educational level, hemodialysis frequency, items of self-care behavior scale, QOL). Normality of data will be check and applied test accordingly.

SelfWrap-Assisted Arteriovenous Fistulas

This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).

Acoustic Analysis of VA Sounds

End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functioning vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. The current recommendation for VA is the native arteriovenous fistula (AVF), surgically created in the forearm by an anastomosis between a vein and an artery. The AVF, despite being the first-choice treatment, is still affected by high non-maturation and early failure rates, requiring in most of the cases, the creation of a new VA. An arteriovenous graft (AVG) is the second choice for a VA. Surgery is done using an artificial plastic tube that connects an artery to a vein. The AVG matures earlier than AVF (2/3 vs 6 weeks), but it is more prone to infections and has lower survival. It would be important to identify patients at risk of VA failure, but there is currently a lack of adequate strategies for surveillance. A continuous monitoring of the VA function would help in identification of reduced blood flow and VA stenosis, that could be treated by interventional radiologists before AVF or AVG complete closure. Over the years, nurses and nephrologists got used to touch the VA and qualitatively evaluate its vibration, named "thrill", and the sounds emitted by the same using their stethoscope. The purpose of this study is to assess the feasibility of VA sound recording and analysis and provide preliminary evidence of VA sound clinical validity and utility to assess, monitor and predict vascular remodelling occurring in AVFs and AVGs. This is a single center prospective observational study involving the acquisition of VA sounds and Doppler US examinations in consenting patients with ESRD. To reach this goal, two groups of ESRD patients in need of VA surgery to perform HD treatment will be involved: Group 1. Patients with AVF as first line HD access option. Group 2. Patients with AVG as first line HD access option.

DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis

The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are: 1. Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons? 2. What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons?

Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure

This study was aimed at comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.This is a prospective, multi-center cohort study.

Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.

This study is a prospective, single-center real-world research, aiming to understand the clinical intervention effects and health economics value of various endovascular treatment methods for arteriovenous graft fistula failure in the real world. The target lesion is defined as the inflow tract (artery, anastomosis, bend), middle segment, and outflow vein of the dialysis pathway. The study will recruit 240 patients with arteriovenous graft fistula failure at a single center from September 2023 to December 2024. Depending on different treatment methods, patients will be divided into several subgroups, such as the simple balloon dilation group, drug balloon group, stent implantation group, etc. As this is a real-world study, the main observations will be the technical success rate of various endovascular treatment methods, major adverse events during the perioperative period, and the symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospital expenditure related to target lesions at 1, 6, 12, 18, and 24 months postoperatively.

Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure

This study was aimed at evaluating the efficacy of different endovascular treatments for early and mid-stage clinical interventions in patients with autologous arteriovenous fistulae loss of function and the corresponding health economic value.

Three-dimensional (3D) Printed Hemodialysis Vascular Model

Infiltration of a surgically-placed hemodialysis vascular access (HVA) is recognized as a major contributor to the high hospital re-admission rate in dialysis-dependent patients. Three dimensional modeling has been demonstrated as a critical tool for procedurists in preparation for surgical interventions but no such modeling is yet available for dialysis specialists to avoid the common complication of HVA infiltration. Contrast enhanced magnetic resonance angiography (MRA) can be used to generate a three dimensional image data that could render a three dimensional resin-based model of a vascular access.