Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141798
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-10-07
Brief Title:
Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients
Sponsor:
Soonchunhyang University Hospital
Organization:
Soonchunhyang University Hospital
Study Overview
Official Title:
A Pragmatic Randomized Clinical Trial Twice-weekly vs Thrice-weekly Incident hemoDialysis in Elderly Patients
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:
None
Brief Summary:
As Korea is becoming a super-aged society the number of elderly patients with end-stage kidney disease ESKD is expected to increase rapidly Therefore the burden on Korean society will also increase
Thrice-weekly hemodialysis is standard for renal replacement therapy However this regimen has not been validated for elderly ESKD patients with residual renal function Elderly patients can have multiple comorbidities such as hypertension diabetes cardiovascular disease and impaired physical activity Frequent hemodialysis could provoke falls hypotension and cognitive impairment Previous reports have suggested the potential benefit of twice-weekly hemodialysis with incremental increases in frequency when residual renal function decreases In addition twice-weekly hemodialysis decreases hospitalization rates in frail patients
Therefore the investigators hypothesized initiating renal replacement therapy with twice-weekly hemodialysis decreases the hopsitalizatoin rates compared with conventional thrice-weekly hemodialysis in elderly ESRD patients with residual renal function This study is a pragmatic randomized clinical trial multicenter study Study subjects are incident ESRD patients 60 years old n428 with residual urine volume 500 mLday and follow up up to 2 years Twice-weekly hemodialysis could be incremented according to clinical situations such as volume overload hyperkalemia and uremic symptom Primary outcome of this study is hospitalization rate during follow-up Secondary outcomes include dialysis related hospitalization rate the length of hospital stay complication of dialysismortality rate and assessments of quality of life frailty and cost-utility
Thrice-weekly hemodialysis is standard for renal replacement therapy However this regimen has not been validated for elderly ESKD patients with residual renal function Elderly patients can have multiple comorbidities such as hypertension diabetes cardiovascular disease and impaired physical activity Frequent hemodialysis could provoke falls hypotension and cognitive impairment Previous reports have suggested the potential benefit of twice-weekly hemodialysis with incremental increases in frequency when residual renal function decreases In addition twice-weekly hemodialysis decreases hospitalization rates in frail patients
Therefore the investigators hypothesized initiating renal replacement therapy with twice-weekly hemodialysis decreases the hopsitalizatoin rates compared with conventional thrice-weekly hemodialysis in elderly ESRD patients with residual renal function This study is a pragmatic randomized clinical trial multicenter study Study subjects are incident ESRD patients 60 years old n428 with residual urine volume 500 mLday and follow up up to 2 years Twice-weekly hemodialysis could be incremented according to clinical situations such as volume overload hyperkalemia and uremic symptom Primary outcome of this study is hospitalization rate during follow-up Secondary outcomes include dialysis related hospitalization rate the length of hospital stay complication of dialysismortality rate and assessments of quality of life frailty and cost-utility
Detailed Description:
End-stage kidney disease ESKD poses a substantial public health challenge with the number of patients requiring renal replacement therapy RRT globally reaching 261 million in 2010 and projected to rise to 543 million by 2030 In Korea the incidence of hemodialysis HD has also been gradually increasing The increase in HD incidence in South Korea is significantly linked to the aging population Korea is one of the most rapidly aging countries in the world and the age of dialysis patients is also increasing with more than half over the age of 60
HD has potential advantages over conservative management or peritoneal dialysis in older adults however guidelines for optimal HD for the elderly have not yet been established Typically patients receive HD three times a week with only a small proportion of patients receiving less frequent dialysis However potential disadvantages such as hemodynamic stress vascular access problems bleeding falls and economic cost should be considered in older adults with ESKD
In elderly patients it is often difficult to maintain a thrice-weekly HD schedule due to the presence of other medical conditions and the challenges of frailty Elderly patients have shown poor outcome even after initiation of HD A study by Santos et al demonstrated a more than twofold increased risk of mortality at 6 months in patients older than 75 years compared to those younger than 75 Another study using Japanese National Dialysis Registry data revealed a 30 mortality rate in those aged over 80 years within 1 year after initiation of HD with frailty being one of the most important factors associated with early death after initiation of HD Excessive HD in elderly patients can lead to malnutrition low blood pressure during dialysis poor quality of life depression and stress due to physical and temporal activity restriction The increased risk of falls in HD patients is also a serious problem
Incremental initiation of HD involves starting HD at a lower intensity than the standard 4 hours thrice weekly and gradually increasing the frequency and duration of dialysis as kidney function declines The decision to initiate patients on incremental HD can be made based on clinical parameters such as urine volume or residual kidney function socio-economic factors such as financial limitations or insurance coverage or lack of availability of dialysis services Current guidelines recommend that twice weekly dialysis be performed in patients with kidney urea clearance greater than 3mlmin173m2 or a urine output over 05 liter per day
A systemic review and meta-analysis showed no difference in mortality hospitalization rates or quality of life between patients receiving incremental and conventional HD with improved preservation of residual renal function and a reduction in dialysis cost with incremental HD One randomized controlled trial RCT showed no difference in episodes of fluid overload or hyperkalemia but an increased risk of hyperkalemia with incremental HD Another study showed lower hospitalization rate in incremental HD compared to conventional dialysis These studies demonstrate the need for a large RCT comparing incremental and conventional HD
However current studies do not provide conclusive evidence on the benefits and risks of incremental HD in elderly patients Therefore the investigators are conducting a pragmatic RCT to determine whether the initiation of renal replacement therapy with twice-weekly HD reduces hospitalization rates compared to conventional thrice-weekly HD in older adults with ESKD
Trial design PRIDE trial is designed as a pragmatic RCT comparing the effect of initiating twice-weekly hemodialysis with an incremental approach compared to thrice-weekly HD on hospitalization rates in elderly ESKD patients with RKF A total of 428 participants will be recruited from 18 academic dialysis centers in Korea Participants will have the flexibility to transfer to other dialysis centers as needed The decision to increase dialysis frequency will be made by the treating physicians
Hypothesis Our main hypothesis is that twice-weekly HD when prescribed to older adults with RKF will reduce hospitalization rates compared with thrice-weekly HD
1 Liyanage T Ninomiya T Jha V et al Worldwide access to treatment for end-stage kidney disease a systematic review Lancet 20153851975-1982
2 Hong YA Ban TH Kang CY et al Trends in epidemiologic characteristics of end-stage renal disease from 2019 Korean Renal Data System KORDS Kidney Res Clin Pract 20214052-61
3 Choi HS Han KD Oh TR et al Trends in the incidence and prevalence of end-stage renal disease with hemodialysis in entire Korean population A nationwide population-based study Medicine Baltimore 2021100e25293
4 Verberne WR Geers AB Jellema WT Vincent HH van Delden JJ Bos WJ Comparative Survival among Older Adults with Advanced Kidney Disease Managed Conservatively Versus with Dialysis Clin J Am Soc Nephrol 201611633-640
5 Corbett RW Brown EA Conventional dialysis in the elderly How lenient should our guidelines be Semin Dial 201831607-611
6 Bieber B Qian J Anand S et al Two-times weekly hemodialysis in China frequency associated patient and treatment characteristics and Quality of Life in the China Dialysis Outcomes and Practice Patterns study Nephrol Dial Transplant 2014291770-1777
7 Santos J Oliveira P Malheiro J et al Predicting 6-Month Mortality in Incident Elderly Dialysis Patients A Simple Prognostic Score Kidney Blood Press Res 20204538-50
8 Yazawa M Kido R Ohira S et al Early Mortality Was Highly and Strongly Associated with Functional Status in Incident Japanese Hemodialysis Patients A Cohort Study of the Large National Dialysis Registry PLoS One 201611e0156951
9 Buemi M Lacquaniti A Bolignano D et al Dialysis and the elderly an underestimated problem Kidney Blood Press Res 200831330-336
10 Wang HH Wu JL Lee YC et al Risk of Serious Falls Between Hemodialysis and Peritoneal Dialysis Patients A Nationwide Population-based Cohort Study Sci Rep 2020107799
11 Caton E Sharma S Vilar E Farrington K Impact of incremental initiation of haemodialysis on mortality a systematic review and meta-analysis Nephrol Dial Transplant 202338435-446
12 Hemodialysis Adequacy Work G Clinical practice guidelines for hemodialysis adequacy update 2006 Am J Kidney Dis 200648 Suppl 1S2-90
13 Kalantar-Zadeh K Unruh M Zager PG et al Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy Am J Kidney Dis 201464181-186
14 Vilar E Kaja Kamal RM Fotheringham J et al A multicenter feasibility randomized controlled trial to assess the impact of incremental versus conventional initiation of hemodialysis on residual kidney function Kidney Int 2022101615-625
15 Murea M Patel A Highland BR et al Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis A Pilot Study Am J Kidney Dis 202280227-240 e221
HD has potential advantages over conservative management or peritoneal dialysis in older adults however guidelines for optimal HD for the elderly have not yet been established Typically patients receive HD three times a week with only a small proportion of patients receiving less frequent dialysis However potential disadvantages such as hemodynamic stress vascular access problems bleeding falls and economic cost should be considered in older adults with ESKD
In elderly patients it is often difficult to maintain a thrice-weekly HD schedule due to the presence of other medical conditions and the challenges of frailty Elderly patients have shown poor outcome even after initiation of HD A study by Santos et al demonstrated a more than twofold increased risk of mortality at 6 months in patients older than 75 years compared to those younger than 75 Another study using Japanese National Dialysis Registry data revealed a 30 mortality rate in those aged over 80 years within 1 year after initiation of HD with frailty being one of the most important factors associated with early death after initiation of HD Excessive HD in elderly patients can lead to malnutrition low blood pressure during dialysis poor quality of life depression and stress due to physical and temporal activity restriction The increased risk of falls in HD patients is also a serious problem
Incremental initiation of HD involves starting HD at a lower intensity than the standard 4 hours thrice weekly and gradually increasing the frequency and duration of dialysis as kidney function declines The decision to initiate patients on incremental HD can be made based on clinical parameters such as urine volume or residual kidney function socio-economic factors such as financial limitations or insurance coverage or lack of availability of dialysis services Current guidelines recommend that twice weekly dialysis be performed in patients with kidney urea clearance greater than 3mlmin173m2 or a urine output over 05 liter per day
A systemic review and meta-analysis showed no difference in mortality hospitalization rates or quality of life between patients receiving incremental and conventional HD with improved preservation of residual renal function and a reduction in dialysis cost with incremental HD One randomized controlled trial RCT showed no difference in episodes of fluid overload or hyperkalemia but an increased risk of hyperkalemia with incremental HD Another study showed lower hospitalization rate in incremental HD compared to conventional dialysis These studies demonstrate the need for a large RCT comparing incremental and conventional HD
However current studies do not provide conclusive evidence on the benefits and risks of incremental HD in elderly patients Therefore the investigators are conducting a pragmatic RCT to determine whether the initiation of renal replacement therapy with twice-weekly HD reduces hospitalization rates compared to conventional thrice-weekly HD in older adults with ESKD
Trial design PRIDE trial is designed as a pragmatic RCT comparing the effect of initiating twice-weekly hemodialysis with an incremental approach compared to thrice-weekly HD on hospitalization rates in elderly ESKD patients with RKF A total of 428 participants will be recruited from 18 academic dialysis centers in Korea Participants will have the flexibility to transfer to other dialysis centers as needed The decision to increase dialysis frequency will be made by the treating physicians
Hypothesis Our main hypothesis is that twice-weekly HD when prescribed to older adults with RKF will reduce hospitalization rates compared with thrice-weekly HD
1 Liyanage T Ninomiya T Jha V et al Worldwide access to treatment for end-stage kidney disease a systematic review Lancet 20153851975-1982
2 Hong YA Ban TH Kang CY et al Trends in epidemiologic characteristics of end-stage renal disease from 2019 Korean Renal Data System KORDS Kidney Res Clin Pract 20214052-61
3 Choi HS Han KD Oh TR et al Trends in the incidence and prevalence of end-stage renal disease with hemodialysis in entire Korean population A nationwide population-based study Medicine Baltimore 2021100e25293
4 Verberne WR Geers AB Jellema WT Vincent HH van Delden JJ Bos WJ Comparative Survival among Older Adults with Advanced Kidney Disease Managed Conservatively Versus with Dialysis Clin J Am Soc Nephrol 201611633-640
5 Corbett RW Brown EA Conventional dialysis in the elderly How lenient should our guidelines be Semin Dial 201831607-611
6 Bieber B Qian J Anand S et al Two-times weekly hemodialysis in China frequency associated patient and treatment characteristics and Quality of Life in the China Dialysis Outcomes and Practice Patterns study Nephrol Dial Transplant 2014291770-1777
7 Santos J Oliveira P Malheiro J et al Predicting 6-Month Mortality in Incident Elderly Dialysis Patients A Simple Prognostic Score Kidney Blood Press Res 20204538-50
8 Yazawa M Kido R Ohira S et al Early Mortality Was Highly and Strongly Associated with Functional Status in Incident Japanese Hemodialysis Patients A Cohort Study of the Large National Dialysis Registry PLoS One 201611e0156951
9 Buemi M Lacquaniti A Bolignano D et al Dialysis and the elderly an underestimated problem Kidney Blood Press Res 200831330-336
10 Wang HH Wu JL Lee YC et al Risk of Serious Falls Between Hemodialysis and Peritoneal Dialysis Patients A Nationwide Population-based Cohort Study Sci Rep 2020107799
11 Caton E Sharma S Vilar E Farrington K Impact of incremental initiation of haemodialysis on mortality a systematic review and meta-analysis Nephrol Dial Transplant 202338435-446
12 Hemodialysis Adequacy Work G Clinical practice guidelines for hemodialysis adequacy update 2006 Am J Kidney Dis 200648 Suppl 1S2-90
13 Kalantar-Zadeh K Unruh M Zager PG et al Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy Am J Kidney Dis 201464181-186
14 Vilar E Kaja Kamal RM Fotheringham J et al A multicenter feasibility randomized controlled trial to assess the impact of incremental versus conventional initiation of hemodialysis on residual kidney function Kidney Int 2022101615-625
15 Murea M Patel A Highland BR et al Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis A Pilot Study Am J Kidney Dis 202280227-240 e221
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?:
None
Is an FDA AA801 Violation?:
None