Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets): A Pragmatic, Multi-Center, Randomized Controlled Trial
退伍军人透析第一年增量血液透析 (IncHVets):一项务实、多中心、随机对照试验
基本信息
- 批准号:10486289
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-10-01 至 2027-09-30
- 项目状态:未结题
- 来源:
- 关键词:AddressAdverse eventAmericanAncillary StudyBlood VesselsCachexiaCardiacCardiovascular systemCaregiver BurdenCaringClient satisfactionClinicClinic VisitsClinicalClinical TrialsCosts and BenefitsDialysis patientsDialysis procedureDoseEatingEligibility DeterminationEmergency department visitEnd stage renal failureEventFatigueFrequenciesFutureGDF15 geneGrowthHealthcare SystemsHemodialysisHospitalizationHuman ResourcesHypotensionHypotensivesImpaired healthInflammationInflammatoryInjury to KidneyInterventionKidneyKidney DiseasesLeftLeft Ventricular MassLifeLongevityMaintenanceMalnutritionMeasuresMedical centerMuscleNutritionalNutritional statusOrganOutcomeOutcome MeasureOutpatientsOutputParentsPatient Outcomes AssessmentsPatientsPhysical FunctionPhysical PerformancePopulationPragmatic clinical trialProteinsProtocols documentationProviderRandomized, Controlled TrialsRegimenRenal functionResearch DesignResearch PersonnelResidual stateResourcesSafetyScheduleSerumSiteSymptomsSystemTestingTimeTime trendUreaUrineVeteransVeterans Health AdministrationWithdrawalarmcopingcostdesignexperiencefrailtyfunctional statushealth care service utilizationhealth related quality of lifehyperkalemiaimprovedindexingmortalitymortality riskmuscle formnutritionphysical conditioningpragmatic studyprecision medicinepreferencepreservationprimary endpointprimary outcomesafety assessmentsafety outcomessafety testingscale upsecondary endpointsecondary outcomestandard of caresurvival predictionwasting
项目摘要
PROJECT SUMMARY
Each year approximately 12,000 Veterans develop end-stage renal disease (ESRD) and initiate dialysis
treatment. These patients comprise >10% of the US incident ESRD population. Dialysis is costly and
associated with impaired health-related quality of life (HRQOL) and high mortality risk, particularly in the first
dialysis year. The current paradigm is to start treatment with full-dose thrice-weekly hemodialysis (HD)
irrespective of patients' residual kidney function (RKF), and this abrupt transition increases patients' and care-
partners' burden and suffering and may limit their preferences. Furthermore, recent evidence suggests that
Veterans who receive dialysis in a VA center have greater survival compared to those treated in non-VA units.
Although not currently the standard of care, evidence suggests that a gradual or incremental dialysis
transition using an initial twice-weekly HD schedule may confer substantial benefits including more dialysis-
free time, longer RKF preservation, vascular access longevity, less intradialytic hypotension and end-organ
damage, reduced post-dialysis fatigue, and less patient suffering. Hence, an incremental dialysis transition
may result in improved HRQOL through improved physical function, less fatigue, greater energy, and
improved patient satisfaction and life participation by mitigating the burden of excessive dialysis in daily life.
Pragmatic studies with immediate clinical impact are urgently needed to shift the focus of dialysis from an
abrupt thrice-weekly HD start to a safe and effective personalized dialysis regimen. Moreover, implementing a
twice-weekly HD schedule would allow 20% more Veterans to receive care within a VA-based dialysis unit.
In the spirit of RFA CX-21-006 for clinical trials, in this multiple-PI, multi-site, pragmatic, 1:1 randomized
controlled trial (RCT), parallel with Veterans' routine dialysis therapy, we will test the safety and efficacy of an
incremental twice-weekly HD protocol, compared to standard-of-care thrice-weekly HD, in Veterans who meet
predefined eligibility criteria. We plan to compare twice-weekly (incremental) with thrice-weekly (conventional)
HD initiation in 252 Veterans with incident ESRD, who will transition to maintenance HD therapy in six VA
centers. Using quarterly assessments for up to 12 months, we will examine the Short Form 36 (SF36) HRQOL
physical component score as the primary outcome, as well as Dialysis Symptom Index and SF36 energy/
fatigue score as secondary endpoints. Additional secondary outcomes will include preservation of RKF,
dialysis adequacy, nutritional status, and protein-energy wasting markers to be measured quarterly. Safety
assessments will include mortality, dialysis withdrawals, emergency room visits, hospitalizations,
hyperkalemia, and major adverse cardiovascular events. In a substudy examining exploratory outcomes in
112 Veterans from three VA centers in the parent trial, we will also examine of cardiac measures including left
ventricular mass, as well as nutritional/physical function indices of muscle mass and physical performance.
Our proposed pragmatic RCT addresses a major unmet need in Veterans with incident ESRD initiating
dialysis by focusing on improving HRQOL and preserving RKF, the two strongest predictors of survival and
patient satisfaction. The results of this study may enable more Veterans to receive therapy in a VA based
dialysis center. Our study may lead to a paradigm shift with immediate impact on kidney care in Veterans and
in the broader ESRD population. The pragmatic design will permit a rapid scaling-up of the interventions in
larger settings since the RCT takes advantage of resources and personnel that are readily available in VA
centers under experienced investigators and clinicians across multiple VA sites nationwide. This proposed
study challenges the current standard of care of outright thrice weekly HD in the first year of dialysis therapy,
during which patients' suffering and mortality are the highest, and is less likely to be supported by for-profit
dialysis providers given the perceived reduction in revenue if twice-weekly HD is to be implemented broadly.
项目总结
项目成果
期刊论文数量(0)
专著数量(0)
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会议论文数量(0)
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Kamyar Kalantar-Zadeh其他文献
Kamyar Kalantar-Zadeh的其他文献
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{{ truncateString('Kamyar Kalantar-Zadeh', 18)}}的其他基金
Plant-Focused Nutrition in Patients with Diabetes and Chronic Kidney Disease (PLAFOND Study): A Pilot/Feasibility Study
糖尿病和慢性肾病患者的植物性营养(PLAFOND 研究):试点/可行性研究
- 批准号:
10586677 - 财政年份:2023
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10587470 - 财政年份:2023
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Defining Optimal Transitions of Care in Advanced Kidney Disease: Conservative Management vs. Dialysis Approaches
定义晚期肾病护理的最佳转变:保守治疗与透析方法
- 批准号:
10436989 - 财政年份:2020
- 资助金额:
-- - 项目类别:
Defining Optimal Transitions of Care in Advanced Kidney Disease: Conservative Management vs. Dialysis Approaches
定义晚期肾病护理的最佳转变:保守治疗与透析方法
- 批准号:
10264944 - 财政年份:2020
- 资助金额:
-- - 项目类别:
Racial and Cardiovascular Risk Factor Anomalies in CKD
CKD 中的种族和心血管危险因素异常
- 批准号:
8635349 - 财政年份:2013
- 资助金额:
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Comparative Effectiveness of Home Hemodialysis versus Kidney Transplantation in t
家庭血液透析与肾移植在治疗中的效果比较
- 批准号:
8741928 - 财政年份:2013
- 资助金额:
-- - 项目类别:
Racial and Cardiovascular Risk Factor Anomalies in CKD
CKD 中的种族和心血管危险因素异常
- 批准号:
8532600 - 财政年份:2013
- 资助金额:
-- - 项目类别:
Racial and Cardiovascular Risk Factor Anomalies in CKD
CKD 中的种族和心血管危险因素异常
- 批准号:
8811934 - 财政年份:2013
- 资助金额:
-- - 项目类别:
Comparative Effectiveness of Home Hemodialysis versus Kidney Transplantation in t
家庭血液透析与肾移植在治疗中的效果比较
- 批准号:
8652787 - 财政年份:2013
- 资助金额:
-- - 项目类别:
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