Clinical Trial End Points for Hemodialysis Vascular Access: Background, Rationale, and Definitions (original) (raw)
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KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update
American Journal of Kidney Diseases, 2020
The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) has provided evidencebased guidelines for hemodialysis vascular access since 1996. Since the last update in 2006, there has been a great accumulation of new evidence and sophistication in the guidelines process. The 2019 update to the KDOQI Clinical Practice Guideline for Vascular Access is a comprehensive document intended to assist multidisciplinary practitioners care for chronic kidney disease patients and their vascular access. New topics include the end-stage kidney disease "Life-Plan" and related concepts, guidance on vascular access choice, new targets for arteriovenous access (fistulas and grafts) and central venous catheters, management of specific complications, and renewed approaches to some older topics. Appraisal of the quality of the evidence was independently conducted by using a Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, and interpretation and application followed the GRADE Evidence to Decision frameworks. As applicable, each guideline statement is accompanied by rationale/background information, a detailed justification, monitoring and evaluation guidance, implementation considerations, special discussions, and recommendations for future research.
Reality check: primary vascular access creation today
Swiss Medical Weekly, 2018
INTRODUCTION: In Switzerland, the outcome of vascular access creation in the 4500 current dialysis patients is unknown, mainly because there is no prospective registry for patients undergoing vascular access surgery for renal replacement therapy. The aim of the study was to assess the quality of vascular access creation and to compare it with the current literature and guidelines, in order to define strategies to improve clinical outcome. METHODS: Retrospective single-centre study in a tertiary referral centre. All consecutive patients over 18 years of age undergoing primary vascular access creation between January 2013 and December 2014 were included. Followup data for at least 12 months were collected. RESULTS: During the study period, 365 patients had a surgical intervention for renal replacement therapy. A primary vascular access was created in 74 patients (20%), who were further analysed in our study: 63 (85%) had an arteriovenous fistula (AVF) and 11 (15%) an arteriovenous graft (AVG). The intervention-free survival (primary patency rate) of the primary vascular access at 1 year was 46% (95% confidence interval [CI] 33-58%) for AVF and 30% (95% CI 7-58%) for AVG, with a secondary patency rate at 1 year of 75% (95% CI 63-84%) for AVF and 50% (95% CI 18-75%) for AVG. Twenty-seven patients (36%) with primary vascular access underwent central venous catheter (CVC) placement (tunnelled or non-tunnelled) before the access creation. Thirty-seven (50%) patients had their first dialysis through a CVC. Thirty-one patients (42%) never received a CVC. CONCLUSIONS: The primary patency of vascular access was unexpectedly low, and the number of CVC requests unexpectedly high. In light of this, we consider it essential that centres creating vascular access should register their activities and compare their outcomes with current guidelines to check and improve clinical management. To facilitate this, there is an initiative starting in 2018 encouraging all Swiss vascular surgeons to provide data on vascular access interventions, including 1-year follow-up, in the national online registry "SwissVasc 2.0".
Journal of Vascular Surgery, 2011
The National Kidney Foundation-Kidney Diseases Outcomes Quality Initiative (KDOQI) for vascular access guidelines state that patients with late-stage chronic kidney disease (CKD) should undergo native arteriovenous fistula (AVF) creation at least 6 months before anticipated start of hemodialysis (HD) treatments to obviate the need for other vascular access types, such as grafts or central catheters. Objective: The objective of this study was to determine the incidence of HD, the functional patency, and associated morbidity of AVFs in patients with late-stage CKD placed according to KDOQI. Methods: Consecutive patients with late-stage CKD who underwent AVF creation using KDOQI guidelines for anatomy between January 2003 and December 2007 at two tertiary academic centers were retrospectively evaluated. Baseline demographics, AVF type, and clinical comorbidities were recorded. Patients were stratified into one of four groups (groups A-D) over the follow-up course based on two end points: patency of their AVF and whether or not they began HD. The ideal primary outcome was AVF maturation and use for HD (group A; cumulative functional patency). Other outcomes included AVF patency but no HD (group B), HD with AVF failure (group C), or no HD and AVF abandonment (ie, death, refused hemodialysis, kidney transplant, or fistula failure; group D). Secondary outcomes were time to first cannulation, complications, and secondary interventions. . Complications encountered were maturation failure for cannulation (15%), focal stenosis requiring intervention (13%), inadequate flows on HD (9%), steal syndrome (9%), and thrombosis (8%). Cumulative functional patency for all AVFs was 19% and 27% at 6 and 12 months, respectively, with a mean number of two interventions per AVF (range, 1-10). Mortality during the study was 23%. Conclusion: Despite successful creation and maturation of a preemptive AVF in nearly two-thirds of patients who started HD during the follow-up and given the following observations: the high overall mortality of the population, the morbidity and costs in secondary procedures of AVF creation, and the high incidence of abandonment, it is unclear if this strategy would demonstrate a benefit in a randomized trial when compared to other access strategies. ( J Vasc Surg 2011;54:760-6.)
American journal of kidney diseases : the official journal of the National Kidney Foundation, 2018
Vascular access outcomes in hemodialysis are critically important for patients and clinicians, but frequently are neither patient relevant nor measured consistently in randomized trials. A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop was convened to discuss the development of a core outcome measure for vascular access. 13 patients/caregivers and 46 professionals (clinicians, policy makers, industry representatives, and researchers) attended. Participants advocated for vascular access function to be a core outcome based on the broad applicability of function regardless of access type, involvement of a multidisciplinary team in achieving a functioning access, and the impact of access function on quality of life, survival, and other access-related outcomes. A core outcome measure for vascular access required demonstrable feasibility for implementation across different clinical and trial settings. Participants advocated for a practical and flexible outco...
Standardized Definitions for Hemodialysis Vascular Access
Seminars in Dialysis, 2011
Vascular access dysfunction is one of the leading causes of morbidity and mortality among endstage renal disease patients 1,2. Vascular access dysfunction exists in all 3 types of available accesses: arteriovenous fistulas, arteriovenous grafts, and tunneled catheters. In order to improve clinical research and outcomes in hemodialysis access dysfunction, the development of a multidisciplinary network of collaborative investigators with various areas of expertise, and common standards for terminology and classification in all vascular access types is required. The North American Vascular Access Consortium (NAVAC) is a newly formed multidisciplinary and multicenter network of experts in the area of hemodialysis vascular access, who include nephrologists and interventional nephrologists from the United States and Canada with: (1) a primary clinical and research focus in hemodialysis vascular access dysfunction, (2) national and internationally recognized experts in vascular access, and (3) a history of productivity measured by peer-reviewed publications and funding among members of this consortium. The consortium's mission is to improve the quality and efficiency in vascular access research, and impact the research in the area of hemodialysis vascular access by conducting observational studies and randomized controlled trials. The purpose of the consortium's initial manuscript is to provide working and standard vascular access definitions relating to (1) epidemiology, (2) vascular access function, (3) vascular access patency, and (4) complications in vascular accesses relating to each of the vascular access types. Complications in maturation and patency in surgically created arteriovenous vascular accesses, arteriovenous fistulas (AVF) and grafts (AVG), and infections and thrombosis in
Vascular Access Management 1: An Overview
Nefroloji hemşireliği dergisi, 2010
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