Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05465044
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2022-07-08
Brief Title:
Incremental Hemodialysis for Veterans in the First Year of Dialysis IncHVets
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Incremental Hemodialysis for Veterans in the First Year of Dialysis IncHVets A Pragmatic Multi-Center Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INCHVETS
Brief Summary:
In this pragmatic clinical trial which will dovetail with Veterans routine outpatient dialysis clinic visits in six VA medical centers the investigators will study 252 Veterans with kidney disease who need to start dialysis treatment If a Veteran is eligible for the study by making enough residual urine heshe will have a 50 chance to be offered the usual three-times-per-week dialysis vs twice-per-week dialysis that is gradually increased to three-times per- week over one year The investigators will compare health-related quality of life how long residual kidney function lasts and other measures including safety in these two groups By conducting this study the investigators hope to understand 1 whether starting dialysis with less frequency is safe effective and can help Veterans and their care-partners to better cope with dialysis and 2 if incremental dialysis can result in major cost benefits to the VA health care system thus allowing more patients to stay in VA dialysis clinics vs being transferred to outside clinics
Detailed Description:
Each year approx 12000 Veterans with worsening kidney disease develop end-stage renal disease ESRD and initiate dialysis treatment They 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 especially in the first dialysis treatment year Currently starting treatment with outright full-dose thrice-weekly hemodialysis HD from the outset of therapy is the standard of care regardless of patients residual kidney function RKF and regardless of patients and care-partners suffering and preferences Although not currently the standard of care evidence suggests that gradual or incremental dialysis transition using an initial twice-weekly HD may confer substantial benefits including more dialysis-free time longer RKF preservation less trauma to patients organs including their dialysis vascular access lower frequency of intradialytic hypotensive events less post-dialysis fatigue and reduced patient suffering Hence incremental dialysis transition may result in improved HRQOL through better physical function less fatigue more energy and better patient satisfaction and life participation by mitigating the burden of excessive dialysis in day-to-day life and on employment Pragmatic studies with immediate impact are needed to shift the focus of dialysis from abrupt thrice-weekly HD start to a safe and effective personalized dialysis regimen
In this multi-site pragmatic 11 randomized controlled trial RCT parallel with Veterans routine dialysis therapy the investigators will test the safety and efficacy of an incremental HD protocol compared to standard-of-care thrice-weekly HD in Veterans who meet the eligibility criteria The investigators plan to compare twice-weekly incremental with thrice-weekly conventional HD initiation in 252 Veterans who will transition to maintenance HD therapy in six VA centers Assessing quarterly for up to 12 months the investigators will study HRQOL physical health score as the primary endpoint as well as dialysis symptom index and energyfatigue score as secondary endpoints Additional secondary outcome measures to collect and examine quarterly include preservation of the RKF dialysis adequacy nutritional status and serum level of Growth Differentiation Factor 15 Safety assessments will include mortality dialysis withdrawals ER visits hospitalizations hyperkalemia and major adverse cardiovascular events In a substudy of 112 participating Veterans in three VA centers the investigators will additionally examine cardiac measures including left ventricular mass as well as mid-arm muscle circumference and physical performance
This pragmatic RCT addresses a major unmet need in those Veterans who initiate dialysis by focusing on improving HRQOL and preserving RKF the two strongest predictors of survival and patients satisfaction The results of the study may enable more Veterans to receive therapy in a VA based dialysis center The study could lead to a paradigm shift with immediate impact on kidney care in Veterans and in the broader population with ESRD The 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
In this multi-site pragmatic 11 randomized controlled trial RCT parallel with Veterans routine dialysis therapy the investigators will test the safety and efficacy of an incremental HD protocol compared to standard-of-care thrice-weekly HD in Veterans who meet the eligibility criteria The investigators plan to compare twice-weekly incremental with thrice-weekly conventional HD initiation in 252 Veterans who will transition to maintenance HD therapy in six VA centers Assessing quarterly for up to 12 months the investigators will study HRQOL physical health score as the primary endpoint as well as dialysis symptom index and energyfatigue score as secondary endpoints Additional secondary outcome measures to collect and examine quarterly include preservation of the RKF dialysis adequacy nutritional status and serum level of Growth Differentiation Factor 15 Safety assessments will include mortality dialysis withdrawals ER visits hospitalizations hyperkalemia and major adverse cardiovascular events In a substudy of 112 participating Veterans in three VA centers the investigators will additionally examine cardiac measures including left ventricular mass as well as mid-arm muscle circumference and physical performance
This pragmatic RCT addresses a major unmet need in those Veterans who initiate dialysis by focusing on improving HRQOL and preserving RKF the two strongest predictors of survival and patients satisfaction The results of the study may enable more Veterans to receive therapy in a VA based dialysis center The study could lead to a paradigm shift with immediate impact on kidney care in Veterans and in the broader population with ESRD The 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CX002382 | OTHER | V A ORD CSRD | None |