View Clinical Trial (Medical Research Study)
Mechanisms and Treatment of Intradialytic Hypertension - Sodium
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Dallas and Irving |
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Texas |
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| Conditions: |
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Hemodialysis - End-stage Renal Disease - Hypertension - Intradialytic Hypertension |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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)
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| NCT ID: |
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NCT01371890 |
| Primary Contact: |
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Principal Investigator
Jula K Inrig, MD, MHS
UT Southwestern Medical Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Dallas and Irving, Texas
United States
Jula Inrig, MD, MHS
Phone: 214-645-8263
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
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