Mechanisms and Treatment of Intradialytic Hypertension - Sodium (MATCH-Sodium)
The purpose of this study is to determine the role of dialysate exposure and fluid removal during hemodialysis in the pathophysiology of intradialytic hypertension.
End-stage Renal Disease
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||Mechanisms and Treatment of Intradialytic Hypertension - Sodium|
- Systolic blood pressure [ Time Frame: crossover studies followup 3-16 weeks ] [ Designated as safety issue: No ]Differences in blood pressure during hemodialysis between treatments
- Endothelial cell function [ Time Frame: crossover studies with followup of 3-16 weeks ] [ Designated as safety issue: No ]Differences in nitric oxide and endothelin-1 across treatments Differences in FMD and ADMA between treatments
Biospecimen Retention: Samples Without DNA
Samples stored for nitric oxide and endothelin-1 measurements
|Study Start Date:||May 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Patients with systolic blood pressure increases > 10 mmHg during 4/6 hemodialysis sessions
Specific Aim #1 To determine in a crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether standard dialysis with ultrafiltration (dialysate Na of 140), dialysis without ultrafiltration (dialysate Na of 140), or ultrafiltration alone (no dialysate) is associated with the an increase in systolic blood pressure during hemodialysis
Specific Aim #2 To determine in a crossover study of 15 maintenance hemodialysis with intradialytic hypertension whether standard dialysis with ultrafiltration, dialysis without ultrafiltration, or ultrafiltration alone is associated with change in either endothelin-1 or nitric oxide during hemodialysis
Specific Aim #1 To determine in a randomized 3-week, 2 period crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether high vs low dialysate-to-serum Na gradients impairs release of NO, increases ET-1 or causes an acute intradialytic increase in systolic BP,.
Specific Aim #2 TO determine in a randomized 16-week, 2-period crossover study of 30 hemodialysis patients with intradialytic hypertension the effects of 8 weeks of high dialysate-to-plasma Na gradients to 8-weeks of low Na gradients on EC function (FMD and ADMA) and 44 hour ambulatory BP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371890
|United States, Texas|
|UT Southwestern DaVita|
|Dallas and Irving, Texas, United States|
|Principal Investigator:||Jula K Inrig, MD, MHS||UT Southwestern Medical Center|