Mechanisms and Treatment of Intradialytic Hypertension - Sodium

Study Overview
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Brief Summary
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The purpose of this study is to determine the role of dialysate exposure and fluid removal during hemodialysis in the pathophysiology of intradialytic hypertension.

Detailed Description
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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 SUBSTUDY AIMS 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.

Official Title
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Mechanisms and Treatment of Intradialytic Hypertension - Sodium

Conditions
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Hemodialysis, End-stage Renal Disease, Hypertension, Intradialytic Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: on hemodialysis > 30 days male and female participants, aged 18 to 85 years old, of all races and ethnic origin ability to provide informed consent Primary nephrologist deems patient is at target dry weight KDOQI defined hypertension (predialysis SBP >140 or postdialysis SBP>130) AND pre to post hemodialysis SBP increase (>10 mmHg) during 4/6 last HD session Exclusion Criteria: Patients with active cancer or active wounds Patient currently on antibiotics or on IV antibiotics within the last month BP unable to be measured by routine mechanisms in the upper extremity Life expectancy < 6 months Inability to provide informed consent Larger interdialytic weight gain (>5 kg/treatment on average)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intradialytic hypertension<br>Patients with systolic blood pressure increases > 10 mmHg during 4/6 hemodialysis sessions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Differences in blood pressure during hemodialysis between treatments | crossover studies followup 3-16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell function | Differences in nitric oxide and endothelin-1 across treatments Differences in FMD and ADMA between treatments | crossover studies with followup of 3-16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, end-stage renal disease, hypertension