A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults with End-Stage Kidney Disease on Hemodialysis: The AV ACCESS Trial
血液透析终末期肾病老年人中瘘管与移植动静脉血管通路的随机试验:AV ACCESS 试验
基本信息
- 批准号:10185381
- 负责人:
- 金额:$ 129.03万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-01 至 2026-08-31
- 项目状态:未结题
- 来源:
- 关键词:AddressAdjuvantAdultAgeAge-YearsAgingAmericanAnatomyAreaArteriovenous fistulaAssessment toolAttentionBiologicalBlood VesselsCannulationsCapsicumCaringCathetersCessation of lifeChronicClient satisfactionClinicalComplexCoronary ArteriosclerosisDataDependenceDiabetes MellitusDiagnosisDialysis procedureDisadvantagedDiseaseEffectiveness of InterventionsElderlyEnd stage renal failureEnrollmentExhibitsFailureFistulaGoalsHand StrengthHealthHealth Care CostsHealth Services AccessibilityHemodialysisHigh PrevalenceHospitalizationIncidenceInfectionInterventionLinkLongevityMeasurementMeasuresMedical centerObservational StudyOperative Surgical ProceduresOutcomeParticipantPatient Outcomes AssessmentsPatient PreferencesPatient riskPatient-Focused OutcomesPatientsPeripheral arterial diseasePhysical FunctionPopulationProceduresRandomizedRandomized Clinical TrialsReportingResearchResearch MethodologyRoleSafetySiteSurfaceTestingThrombosisTimeVascular GraftVenousarteriovenous graftbasecare preferenceclinical practicecomorbiditycomparativecostdisabilityeconomic outcomeeligible participantevidence basefeasibility testingfollow-upfrailtyhuman old age (65+)infection rateinfection risknovelolder patientpilot trialprimary outcomepublic health prioritiesrandomized trialrepairedresearch studysafety outcomessatisfactiontrait
项目摘要
ABSTRACT
End-stage kidney disease is a disease of aging, exacerbated by multiple coexisting health conditions. Nearly
50% of patients initiating chronic hemodialysis for treatment of end-stage kidney disease are 65 years or older.
Patients who use central venous catheters for hemodialysis access typically undergo surgical placement of an
arteriovenous access—either a fistula or a graft—to reduce the risks of infection, vascular complications and
death associated with catheter use. Arteriovenous fistulas have long been considered first-line vascular access
option, with grafts as second best. However, several recent studies suggest that grafts may be a better
strategy than fistulas for hemodialysis access in older adults. Without evidence from well-powered randomized
clinical trials, these studies cannot be integrated into practice. We conducted the first pilot trial (N=46) that
revealed the feasibility of enrolling and randomizing older adults to surgical fistula or graft placement, with 89%
(20 of 22) of those assigned to fistula and 79% (19 of 24) of those assigned to graft placement undergoing the
assigned intervention. Building on this successful pilot, we propose a pragmatic multicenter randomized clinical
trial in 262 adults, 65 years of age and older, receiving hemodialysis via catheters. Unbiased, comparative
characterization of clinical outcomes and patient views between alternative access strategies will advance the
field, for the first time, to evidence-based vascular access care. Our long-term goals are to optimize clinical
decisions based on objective, age-specific data while incorporating goals of care and patient preference for
vascular access type. The objective of this proposal is to delineate vascular access effects on disease-specific
and patient-reported outcomes, using a randomized intervention, at 6 national sites, of surgical fistula versus
graft placement in older adults who have end-stage kidney disease and coexisting coronary artery disease,
peripheral arterial disease, and/or diabetes mellitus. The overarching hypothesis is that graft placement
strategy will yield more dialysis catheter-free days, lower cost, and better patient satisfaction. Our Specific
Aims will determine the effects of fistula versus graft vascular access strategy on rates of catheter-free dialysis
days and access-related infections and death (Primary Aim), costs associated with vascular access care
(Secondary Aim), and patient-reported satisfaction with access-related outcomes (Tertiary Aim). We will also
investigate the relationship between preoperative objective and subjective measures of physical function and
failure of fistula or graft maturation (Exploratory Aim). Results from this trial could transform the clinical practice
by providing high-quality evidence to guide common clinical decisions on dialysis vascular access in older
adults—a growing population whose care is complex and costly.
摘要
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
MICHAEL ALLON其他文献
MICHAEL ALLON的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('MICHAEL ALLON', 18)}}的其他基金
A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults with End-Stage Kidney Disease on Hemodialysis: The AV ACCESS Trial
血液透析终末期肾病老年人中瘘管与移植动静脉血管通路的随机试验:AV ACCESS 试验
- 批准号:
10684934 - 财政年份:2021
- 资助金额:
$ 129.03万 - 项目类别:
Barriers to arteriovenous fistula use in black hemodialysis patients
黑人血液透析患者使用动静脉内瘘的障碍
- 批准号:
10330375 - 财政年份:2019
- 资助金额:
$ 129.03万 - 项目类别:
Barriers to arteriovenous fistula use in black hemodialysis patients
黑人血液透析患者使用动静脉内瘘的障碍
- 批准号:
10084716 - 财政年份:2019
- 资助金额:
$ 129.03万 - 项目类别:
Barriers to arteriovenous fistula use in black hemodialysis patients
黑人血液透析患者使用动静脉内瘘的障碍
- 批准号:
10551916 - 财政年份:2019
- 资助金额:
$ 129.03万 - 项目类别:
Choice of vascular access and patient outcomes among older hemodialysis patients
老年血液透析患者血管通路的选择和患者预后
- 批准号:
8967295 - 财政年份:2015
- 资助金额:
$ 129.03万 - 项目类别:
Vascular abnormalities in patients receiving a dialysis access.
接受透析的患者的血管异常。
- 批准号:
7984169 - 财政年份:2010
- 资助金额:
$ 129.03万 - 项目类别:
Vascular abnormalities in patients receiving a dialysis access.
接受透析的患者的血管异常。
- 批准号:
8296317 - 财政年份:2010
- 资助金额:
$ 129.03万 - 项目类别:
Vascular abnormalities in patients receiving a dialysis access.
接受透析的患者的血管异常。
- 批准号:
8494041 - 财政年份:2010
- 资助金额:
$ 129.03万 - 项目类别:
Vascular abnormalities in patients receiving a dialysis access.
接受透析的患者的血管异常。
- 批准号:
8089392 - 财政年份:2010
- 资助金额:
$ 129.03万 - 项目类别:
HEMODIALYSIS VASCULAR ACCESS CLINICAL TRIALS CONSORTIUM
血液透析血管通路临床试验联盟
- 批准号:
6728229 - 财政年份:2002
- 资助金额:
$ 129.03万 - 项目类别:
相似海外基金
Metachronous synergistic effects of preoperative viral therapy and postoperative adjuvant immunotherapy via long-term antitumor immunity
术前病毒治疗和术后辅助免疫治疗通过长期抗肿瘤免疫产生异时协同效应
- 批准号:
23K08213 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Improving the therapeutic immunity of cancer vaccine with multi-adjuvant polymeric nanoparticles
多佐剂聚合物纳米粒子提高癌症疫苗的治疗免疫力
- 批准号:
2881726 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别:
Studentship
Evaluation of the Sensitivity to Endocrine Therapy (SET ER/PR) Assay to predict benefit from extended duration of adjuvant endocrine therapy in the NSABP B-42 trial
NSABP B-42 试验中内分泌治疗敏感性 (SET ER/PR) 测定的评估,用于预测延长辅助内分泌治疗持续时间的益处
- 批准号:
10722146 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别:
Countering sympathetic vasoconstriction during skeletal muscle exercise as an adjuvant therapy for DMD
骨骼肌运动期间对抗交感血管收缩作为 DMD 的辅助治疗
- 批准号:
10735090 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别:
AUGMENTING THE QUALITY AND DURATION OF THE IMMUNE RESPONSE WITH A NOVEL TLR2 AGONIST-ALUMINUM COMBINATION ADJUVANT
使用新型 TLR2 激动剂-铝组合佐剂增强免疫反应的质量和持续时间
- 批准号:
10933287 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别:
DEVELOPMENT OF SAS A SYNTHETIC AS01-LIKE ADJUVANT SYSTEM FOR INFLUENZA VACCINES
流感疫苗类 AS01 合成佐剂系统 SAS 的开发
- 批准号:
10935776 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别:
DEVELOPMENT OF SMALL-MOLECULE DUAL ADJUVANT SYSTEM FOR INFLUENZA VIRUS VACCINE
流感病毒疫苗小分子双佐剂体系的研制
- 批准号:
10935796 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别:
A GLYCOLIPID ADJUVANT 7DW8-5 FOR MALARIA VACCINES
用于疟疾疫苗的糖脂佐剂 7DW8-5
- 批准号:
10935775 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别:
Adjuvant strategies for universal and multiseasonal influenza vaccine candidates in the context of pre-existing immunity
在已有免疫力的情况下通用和多季节流感候选疫苗的辅助策略
- 批准号:
10649041 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别:
Adjuvant Photodynamic Therapy to Reduce Bacterial Bioburden in High-Energy Contaminated Open Fractures
辅助光动力疗法可减少高能污染开放性骨折中的细菌生物负载
- 批准号:
10735964 - 财政年份:2023
- 资助金额:
$ 129.03万 - 项目类别: