Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04692636
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-12-29
Brief Title:
BP Variability on the Outcomes of Hemodialysis Vascular Access
Sponsor:
National Taiwan University Hospital Hsin-Chu Branch
Organization:
National Taiwan University Hospital Hsin-Chu Branch
Study Overview
Official Title:
Investigating the Impact of Blood Pressure Variability on the Outcomes of Hemodialysis Vascular Access
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
Hemodialysis vascular access dysfunction continues to be a major source of morbidity and mortality in patients with ESRD Thrombosis is the most common cause of secondary vascular access failure Although intimal hyperplasia at the outflow vein is the most common cause of thrombosis 20-40 of thrombosis may develop secondary without underlying anatomic abnormalities Low-flow states secondary to low BP have been proposed to precipitate access thrombosis In previous studies lower pre- and post- dialysis SBP are associated with a higher rate of access thrombosis Nonetheless high blood pressure is also a well-known risk factor for arteriosclerosis intimal hyperplasia and thrombotic vascular events In dialysis patients the relation between blood pressure and thrombosis seems to be more complex and few studies have delineated the effect of blood pressure in a systematic manner
In addition to the static component of blood pressure blood pressure variability BPV is increasingly accepted as a novel risk factors for vascular disease BPV is categorized as either long or short term In dialysis patients long-term BPV is typically defined on the basis of BP measurements taken at the start of hemodialysis inter-dialysis BPV short-term BPV is usually considered in terms of variability during hemodialysis intra-dialysis BPV BP variability is increased in ESRD patients and is associated with adverse outcomes To the best of our knowledge only one study by Cheung et al focused on intra-dialytic BPV which found intradialytic hypotension to be a risk factor for access thrombosis Nonetheless access thrombotic events rarely occur during the dialysis session It remained unclear that if inter-dialysis BPV is a more relevant factor for access thrombosis Answer to this question is of clinical significance because the optimal BP target after PTA remained unknown In this study we aimed to investigate the effect of BP variability on the outcomes of hemodialysis vascular access major cardiovascular events in maintenance hemodialysis patients We also aimed to evaluate the determinants of BPV in hemodialysis patients including medication frailty fluid status and autonomic function The impact of autonomic function and frailty on the outcomes of vascular access and cardiovascular events will be evaluated as well
In addition to the static component of blood pressure blood pressure variability BPV is increasingly accepted as a novel risk factors for vascular disease BPV is categorized as either long or short term In dialysis patients long-term BPV is typically defined on the basis of BP measurements taken at the start of hemodialysis inter-dialysis BPV short-term BPV is usually considered in terms of variability during hemodialysis intra-dialysis BPV BP variability is increased in ESRD patients and is associated with adverse outcomes To the best of our knowledge only one study by Cheung et al focused on intra-dialytic BPV which found intradialytic hypotension to be a risk factor for access thrombosis Nonetheless access thrombotic events rarely occur during the dialysis session It remained unclear that if inter-dialysis BPV is a more relevant factor for access thrombosis Answer to this question is of clinical significance because the optimal BP target after PTA remained unknown In this study we aimed to investigate the effect of BP variability on the outcomes of hemodialysis vascular access major cardiovascular events in maintenance hemodialysis patients We also aimed to evaluate the determinants of BPV in hemodialysis patients including medication frailty fluid status and autonomic function The impact of autonomic function and frailty on the outcomes of vascular access and cardiovascular events will be evaluated as well
Detailed Description:
Hemodialysis vascular access dysfunction continues to be a major source of morbidity and mortality in patients with ESRD1 After the publication of the dialysis outcome quality initiative guidelines endovascular interventions gradually replaced surgical revisions as the primary treatment of dysfunctional dialysis access2 Although percutaneous transluminal angioplasty PTA can achieve a high success rate recurrent stenosis and thrombosis are usually inevitable3 4 As a result repeated interventions are required and cause a substantial financial burden on the health care system Intimal hyperplasia at the outflow vein is the most common cause of vascular access dysfunction5 Thrombosis may develop secondary to outflow venous stenosis but it can also develop without underlying anatomic abnormalities6
Thrombosis is the most common cause of secondary vascular access failure ie failure of functioning vascular access and is associated with luminal stenosis in 60 to 80 of cases However because 20 to 40 of cases of access thrombosis occur in the absence of stenosis and because not all stenotic accesses thrombose other factors must contribute to access thrombosis7 Among other factors low-flow states secondary to low BP have been proposed to precipitate access thrombosis8 These putative causes of access thrombosis make intuitive sense but few studies have actually examined these factors in a systematic manner
The relation between blood pressure and access thrombosis is complex Very few studies have addressed on this issue Unlike in the general population blood pressure is not linearly associated with adverse outcomes in hemodialysis patients Traditionally high blood pressure is a well-known risk factors of intimal hyperplasia and thrombosis Nonetheless lower BP may also lead to decreased access blood flow which has been shown to independently predict subsequent access thrombosis9 In addition to the static component of blood pressure blood pressure variability BPV is closely associated with adverse outcomes in patients with or at risk of vascular disease than usual BP10 They may play a causal role in the progression of organ damage and in triggering vascular events BPV is categorized as either long or short term based on the time interval over which it is considered11 Long term BPV is usually measured as visit-to-visit BPV and can be considered in intervals of days weeks or months In the dialysis patients the long term BPV is typically defined on the basis of BP measurements taken at the start of hemodialysis treatment inter-dialytic BPV Short-term BPV is usually measured by ambulatory BP monitoring or during specified short-time intervals Among dialysis patients short-term BPV can be considered in terms of variability that occurred during hemodialysis treatment intra-dialytic BPV
4 BP variability is known to be increased in patients with ESRD12 Among patients undergoing hemodialysis potential causes of high BP variability such as baroreceptor dysfunction aortic stiffness and variations in intravascular volume as well as plausible outcomes such as cerebral small-vessel disease cerebral hemorrhage and cardiac sudden death are increased compared to the general population13 14 Therefore increased BP variability may provide a potential explanation for access thrombosis among patients undergoing hemodialysis Currently only one study by Cheung et al has focused on the effect of BP variability Lower pre-and post- dialysis SBP is associated with a higher rate of access thrombosis consistent with previous studies15 16 More importantly intradialytic hypotension is also a risk factor for access thrombosis and may account for some of the 20 to 40 of cases without obvious structural abnormalities16 Nonetheless most access thrombotic events did not occur during the dialysis session It remained unclear if inter-dialysis BP variability is also a risk factor for vascular access thrombosis The answer to these queries is of therapeutic relevance because the achievement of the recommended target BP in dialysis patients may be associated with higher rates of inter- or intra-dialytic hypotension17 Accordingly we aimed to investigate the effect of intra-dialysis BPV inter-dialysis BPV and intra-dialysis hypotension on thrombosis of hemodialysis vascular accessWe also aimed to evaluate the determinants of BPV in hemodialysis patients including medication frailty fluid status and autonomic function The impact of autonomic function and frailty on the outcomes of vascular access and cardiovascular events will be evaluated as well
Thrombosis is the most common cause of secondary vascular access failure ie failure of functioning vascular access and is associated with luminal stenosis in 60 to 80 of cases However because 20 to 40 of cases of access thrombosis occur in the absence of stenosis and because not all stenotic accesses thrombose other factors must contribute to access thrombosis7 Among other factors low-flow states secondary to low BP have been proposed to precipitate access thrombosis8 These putative causes of access thrombosis make intuitive sense but few studies have actually examined these factors in a systematic manner
The relation between blood pressure and access thrombosis is complex Very few studies have addressed on this issue Unlike in the general population blood pressure is not linearly associated with adverse outcomes in hemodialysis patients Traditionally high blood pressure is a well-known risk factors of intimal hyperplasia and thrombosis Nonetheless lower BP may also lead to decreased access blood flow which has been shown to independently predict subsequent access thrombosis9 In addition to the static component of blood pressure blood pressure variability BPV is closely associated with adverse outcomes in patients with or at risk of vascular disease than usual BP10 They may play a causal role in the progression of organ damage and in triggering vascular events BPV is categorized as either long or short term based on the time interval over which it is considered11 Long term BPV is usually measured as visit-to-visit BPV and can be considered in intervals of days weeks or months In the dialysis patients the long term BPV is typically defined on the basis of BP measurements taken at the start of hemodialysis treatment inter-dialytic BPV Short-term BPV is usually measured by ambulatory BP monitoring or during specified short-time intervals Among dialysis patients short-term BPV can be considered in terms of variability that occurred during hemodialysis treatment intra-dialytic BPV
4 BP variability is known to be increased in patients with ESRD12 Among patients undergoing hemodialysis potential causes of high BP variability such as baroreceptor dysfunction aortic stiffness and variations in intravascular volume as well as plausible outcomes such as cerebral small-vessel disease cerebral hemorrhage and cardiac sudden death are increased compared to the general population13 14 Therefore increased BP variability may provide a potential explanation for access thrombosis among patients undergoing hemodialysis Currently only one study by Cheung et al has focused on the effect of BP variability Lower pre-and post- dialysis SBP is associated with a higher rate of access thrombosis consistent with previous studies15 16 More importantly intradialytic hypotension is also a risk factor for access thrombosis and may account for some of the 20 to 40 of cases without obvious structural abnormalities16 Nonetheless most access thrombotic events did not occur during the dialysis session It remained unclear if inter-dialysis BP variability is also a risk factor for vascular access thrombosis The answer to these queries is of therapeutic relevance because the achievement of the recommended target BP in dialysis patients may be associated with higher rates of inter- or intra-dialytic hypotension17 Accordingly we aimed to investigate the effect of intra-dialysis BPV inter-dialysis BPV and intra-dialysis hypotension on thrombosis of hemodialysis vascular accessWe also aimed to evaluate the determinants of BPV in hemodialysis patients including medication frailty fluid status and autonomic function The impact of autonomic function and frailty on the outcomes of vascular access and cardiovascular events will be evaluated as well
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