View clinical trials related to Hemodialysis Access Failure.
Filter by:Hemodialysis vascular access dysfunction continues to be a major source of morbidity and mortality in patients with ESRD. Thrombosis is the most common cause of secondary vascular access failure Although intimal hyperplasia at the outflow vein is the most common cause of thrombosis, 20-40% of thrombosis may develop secondary without underlying anatomic abnormalities. Low-flow states secondary to low BP have been proposed to precipitate access thrombosis. In previous studies, lower pre- and post- dialysis SBP are associated with a higher rate of access thrombosis. Nonetheless, high blood pressure is also a well-known risk factor for arteriosclerosis, intimal hyperplasia, and thrombotic vascular events. In dialysis patients, the relation between blood pressure and thrombosis seems to be more complex, and few studies have delineated the effect of blood pressure in a systematic manner. In addition to the static component of blood pressure, blood pressure variability (BPV) is increasingly accepted as a novel risk factors for vascular disease. BPV is categorized as either long or short term. In dialysis patients, long-term BPV is typically defined on the basis of BP measurements taken at the start of hemodialysis (inter-dialysis BPV); short-term BPV is usually considered in terms of variability during hemodialysis (intra-dialysis BPV). BP variability is increased in ESRD patients and is associated with adverse outcomes. To the best of our knowledge, only one study by Cheung et al focused on intra-dialytic BPV, which found intradialytic hypotension to be a risk factor for access thrombosis. Nonetheless, access thrombotic events rarely occur during the dialysis session. It remained unclear that if inter-dialysis BPV is a more relevant factor for access thrombosis. Answer to this question is of clinical significance because the optimal BP target after PTA remained unknown. In this study, we aimed to investigate the effect of BP variability on the outcomes of hemodialysis vascular access, major cardiovascular events in maintenance hemodialysis patients. We also aimed to evaluate the determinants of BPV in hemodialysis patients, including medication, frailty, fluid status and autonomic function. The impact of autonomic function and frailty on the outcomes of vascular access and cardiovascular events will be evaluated as well.
This is database designed to explore clinical outcomes related to vascular assess in the population of Northern Ireland with CKD Stage 5 and End-stage Renal Failure.
Taiwan was among the countries with high prevalence of end stage renal disease (ESRD), and more than 90% of ESRD patients in Taiwan received hemodialysis. Thrombosis are the most common complications of hemodialysis vascular access, with an annual incidence of 30-65% for dialysis grafts. Although endovascular thrombectomy is effective and convenient, the recurrence rate was high, nearly 50% in three months. The mechanisms of dialysis vascular access thrombosis were multi-factorial, including flow stasis, endothelial injury and hypercoagulability. Our recent study showed that 63% of patients with early thrombosis after angioplasty had at least one thrombophilic factor. Nonetheless, no antithrombotic regimen has been validated to be effective for prevention of thrombosis, either primary or secondary prevention. Novel oral anticoagulants (NOACs) have shown comparable efficacy as VKA with significant decrease in major bleeding. Furthermore, NOACs have the advantage of rapid onset without the need for titration, which should be more effective in the critical period early after thrombectomy. NOAC have almost replaced the role of VKA for the prevention of stroke in patients with atrial fibrillation. They also replaced oral and parenteral anticoagulants in the treatment and prevention of deep vein thrombosis. Among the 4 available NOACs today, only apixaban had received approval by the US Food and Drug Administration (FDA) to be used in patients with ESRD for stroke prevention in atrial fibrillation. In consideration of the trade-off between thrombotic and bleeding risk, we aimed at secondary prevention for patients with a thrombosis event after a successful thrombectomy procedure. Apixaban would be used because it was approved by FDA for the use of hemodialysis patients, with a risk of major bleeding of 5% for 3 months. Furthermore, considering the ethnic (Asia population) and clinical (ESRD and high bleeding risk) background of our target population, 2.5 mg twice daily dose was chosen in this study to minimize the bleeding risk. This study is a multi-center, prospective, open-labeled, randomized trial with blinded evaluation of all outcomes (PROBE design). We anticipated to enroll 150 patients, with 1:1 randomization to apixaban and control group (no antithrombotic agent). The duration of therapy will be 3 months and the primary outcome is the time to recurrent thrombotic event. Secondary outcomes included frequency of thrombosis, repeat interventions, and bleeding events. We hypothesized that apixaban could prolong the thrombosis-free interval after a successful thrombectomy procedure of hemodialysis vascular access.
Vascular access creation in patients with renal failure requiring long-term hemodialysis can be a challenge when there is no more autologous material or in case of infection, in a population undergoing long term dialysis with a longer life-expectancy. Many types of grafts have been used, with its advantages and drawbacks, such as prosthetic grafts (PTFE). Over the past decade, surgeons have used cold stored venous allografts as a biological conduit for hemodialysis, with the idea of avoiding most of major complications including a lower incidence of infection and steal syndrome, with patencies at least equivalent to PTFE. There is only a few data in the litterature, but many surgical teams use it when there is no autologous material or in case of infection. The aim of the study is to give the primary patency of vascular access with this technique, and to assess its long term outcomes.
The arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis(HD), and fistula-first is the general recommendation for all HD patients. But in clinical practice in China, quite a few patients start HD before AVF maturation due to various situations. Whether HD initiation with mature AVF will influence the patency and complications is controversial. This study is aim to compare the AVF patency in incident HD patients with mature or immature AVF on HD initiation, and to compare other clinical outcomes, including abandonment without use, infection, and other AVF complications occurrence.
Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis. Conventional plain old balloon angioplasty is associate with high recurrence rates of stenosis and repeated interventions. The advent of successful drug-eluting technology in the treatment of the coronary vascular bed and subsequent positive accumulating evidence in the peripheral arterial circulation has prompted the use of drug coated balloons (DCB) in the access fistula circuit for venous stenosis and in-stent restenosis. Recent studies suggest that DCBs may significantly reduce re-intervention rates on native and recurrent lesions. The restenosis process is in part or in whole the result of neo-intimal hyperplasia (NIH) and NIH is considered the main culprit in access circuit target lesion stenosis. NIH is the blood vessel's healing response to the barotrauma from the angioplasty process. A critical component of NIH is the cellular proliferative stage with mononuclear leucocytes identified as the primary inflammatory cell type involved. The rationale for drug elution is to block the NIH response with an anti-metabolite such as paclitaxel. It is important to emphasize that the role of drug elution in the treatment of vascular stenosis is not to obtain a good haemodynamic and luminal result but to preserve a good result obtained during POBA from later restenosis due to NIH and minimise reinterventions and readmissions to hospital for what is a frail population of patients. A meta-analysis performed by Khawaja et al. seemed to suggest that DCBs conferred some benefit in terms of improving target lesion primary patency (TLPP) in AVFs. An updated meta-analysis performed by our own institution recently showed that DCB appears to be a better and safe alternative to conventional balloon angioplasty (CBA) in treating patients with HD stenosis based on 6- and 12-months primary patency and increased intervention free period. The Passeo-18 Lux (Biotronik Asia Pacific Pte Ltd (Singapore)) drug-coated balloon (DCB) is packaged with a low dose of paclitaxel. Recent studies have shown that low dose coating of paclitaxel with this DCB is useful for preventing restenosis, decrease lumen loss and target lesion revascularization in the peripheral vasculature6 but has not been tested in the dialysis access circuit.
This prospective, multicenter, non-randomized, single-arm Clinical trial aims to evaluate the safety and effectiveness of the use of paclitaxel-coated arteriovenous graft (AVG) on the inner wall of ePTFE graft, which is designed to reduce neointimal hyperplasia that causes stenosis and thrombosis after implantation of AVG.
Background: There are several studies that document the safety and efficacy of the balloon-assisted maturation (BAM) technique. Ultimately, there are also studies that report its possible negative consequences such as fibrosis and restenosis of venous outflow, leading to malfunctioning arteriovenous fistula (AVF). Thus, in an effort to increase the number of primary AVFs, shorten maturation times, and reduce the number of indwelling catheters, we ascertain the BAM technique within this study to optimize access care and maximize use of AVFs. The balloon assisted maturation approach specifically and aggressively dilates the entire usable segment of the AVF. Methods: This is a randomized prospective study conducted in the department of vascular surgery, Mansoura University Hospitals, including patients with hemodialysis access creation between June 2017 and May 2019. Three hundred patients were recruited from a total of 648 primary AVF creation cases. Patients were divided into two groups; Group (A) Balloon assisted maturation (BAM) (n=157) 52.3 % technique had been done while in the other Group (B) the usual maneuver was used (NO BAM) (n=143) 47.7%. Preoperative duplex was done for all cases to assess suitability. Intraoperative venography was the initial step following surgical exposure of the assigned veins to ascertain continuity and unlimited flow of the superficial vein. Balloon dilatation by 1 mm larger than the size of the vein, sparing the spatulated end of the vein followed by post-dilatation venography to reveal any injury and assess the success of dilatation process. All cases were completed as an end to side anastomosis. Patients were followed clinically and radiologically at regular visits in the 2nd, 4th and 6th week post-procedure, assessing the flow rate, vein depth and diameter via duplex US examination. Results: Patients age ranged from 19 to 89 (mean 51.17 ±15.5) years. The average maturation time was 3.7 weeks (SD ± 1.3 w) and 5.91 weeks (SD ± 2.2 w) for the BAM and non-BAM groups, respectively. Eighty-seven cases (88.7 %) with a pre-operative vein diameter of 3 mm or less, that underwent BAM showed early maturation and started dialysis within 2-4 weeks (68 cases 70%). On the other hand, 28 cases (45.2%) with a vein diameter equal or less than 3 mm in the NO BAM group failed to get mature. Both successful functional maturation (95%) and complication rates (9.6 %) were higher among cases of the BAM group compared to 80.4% maturation rate and 5 % complication in the NO BAM group. The higher complication rate may be attributed to the large number of cases. Conclusion: Balloon-assisted maturation has a pivotal role to help the dialysis society meet the goals of the Fistula First Initiative; It can achieve an accelerated functional maturation of AVF in cases of small caliber veins, with access to early dialysis, thus decreasing the indwelling catheter-related complications.
Chronic Kidney disease (CKD) is a worldwide public health problem that classified into five stages (1). End stage renal disease (CDK stage 5) patients require a well-functioning vascular access (VA) for successful hemodialysis treatment (2). Types of VA include arteriovenous fistulae (AVFs) and arteriovenous grafts (AVGs). A vascular access is liable to early or late complications, and ultimately access failure. A meta-analysis showed that a 17% mean early access failure However recent studies have shown higher failure rates of up to 46%, with one year patencies between 52% to 83% (3). Low VA flow, thrombosis and loss of patency may result in under-dialysis that leads to increased morbidity, mortality and healthcare expenditure (4). In the majority of VAs, stenoses develop over variable intervals causing VA thrombosis and failure (5). If early detected and corrected, VA function and patency can be preserved and under-dialysis can be minimized or avoided. The aim of this study is to find out the role of periodic surveillance of VA in the detection of VA dysfunction and correctable lesions that may necessitate pre-emptive interventions to maintain VA patency and prevent VA loss