Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259714
Status:
TERMINATED
Last Update Posted:
2016-07-22
First Post:
2005-11-28
Brief Title:
Dialysate Sodium Individualization in Hemodialysis
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients
Status:
TERMINATED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol was not feasible - only 1 of 18 enrollees completed procedures
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Salt and water excess is an essential mechanism of hypertension This is particularly relevant to patients with end stage kidney disease ESKD on dialysis We have demonstrated that individualization of the sodium concentration in the dialysate as to match the patients own serum sodium concentration leads to less thirst interdialytic weight gain and better BP control in hypertensive patients In this study we will evaluate the mechanisms underlying this response by measuring systemic hemodynamics body volume spaces and biochemical marker of volume status
Detailed Description:
Recent evidence from our group shows that individualization of the sodium concentration in the dialysate to match the patients own serum sodium results in less thirst less interdialytic weight gain less HD-related symptoms and better blood pressure control in hypertensive subjects In this project we will evaluate the effect of dialysate sodium individualization on systemic hemodynamics body volume compartments and biochemical markers of volume control in hypertensive hemodialysis patients We will use a single-blind cross-over design with randomized blocks After a 3-week baseline period where pre-HD serum sodium will be measured weekly to establish each patients average serum sodium subjects will be randomized to 3 weeks on standard dialysate sodium 140 mmolL or individualized dialysate sodium same concentration as the average pre-HD serum sodium during the baseline period then crossed over to the other for another 3 weeks after a 1-week washout period dialysate Na 140 mmolL The remainder of the dialysis prescription prescribed dry weight and vasoactive drugs will remain unchanged throughout the study Clinical information preintrapost-HD blood pressure and thirst scores will be measured weekly at the mid-week dialysis session In addition we will measure systemic hemodynamics cardiac output and systemic vascular resistance bioimpedance measurements of intracellular and extracellular volume arterial stiffness aortic augmentation index aortic pulse wave velocity interdialytic 44h ambulatory BP monitoring and plasma BNP renin aldosterone and norepinephrine at baseline and at the end of each block
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10349781R0679172168802 | None | None | None |