Mechanisms of Intradialytic Hypertension

Study Overview
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Brief Summary
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Patients with end-stage renal disease (ESRD) are at significantly higher risk for death due to cardiovascular disease. Those with paradoxical increases in blood pressure (BP) during hemodialysis (HD), defined as intradialytic hypertension (IDH), are at even greater risk of cardiovascular mortality. This study seeks to determine the mechanisms that underlie IDH, and whether mindfulness meditation might improve BP during dialysis in these patients. The investigators will first determine if increased adrenaline levels during volume removal contributes to IDH. The investigators will then determine lack of suppression of adrenaline levels in the setting of a high BP also contributes to IDH. This will be done by manipulating blood pressure by using small amounts of vasoactive drugs, and determining if an appropriate response in adrenaline levels occurs. Lastly, the investigators will determine if an intradialytic mindfulness meditation program improves BP and adrenaline levels in ESRD patients with IDH.

Official Title
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Sympathetic Regulation in Intradialytic Hypertension

Conditions
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Renal Failure Chronic Requiring Hemodialysis, Haemodialysis-induced Symptom, Hypertension

Intervention / Treatment
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* Other: Mindfulness Meditation
* Other: Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ESRD patients on maintenance hemodialysis for at least 6 months, with increased blood pressure during hemodialysis Exclusion Criteria: drug or alcohol abuse any serious systemic disease that might influence survival severe anemia with hgb level <8 g/dL clinical evidence of congestive heart failure ejection fraction below 35% myocardial infarction or cerebrovascular accident within the past six months symptomatic heart disease determined by electrocardiogram, stress test, and/or history treatment with central alpha agonists or monoamine oxidase (MAO) inhibitors peripheral neuropathy autonomic dysfunction pregnancy surgery within the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Mindfulness Based Stress Reduction (MBSR) Program<br>After individual instruction, participants in this arm will perform meditation by following a series of mindfulness meditation (MM) recordings during hemodialysis for the next 4 to 8 weeks.The MM instructor will also meet with the participants weekly to provide continued instruction. Participants will also be encouraged to perform MM using a digital audio (MP3) player at home on non-dialysis days, and asked to keep a log of these sessions. | Other: Mindfulness Meditation<br> <br> |
| Placebo Comparator: Health Education<br>Participants randomized to the control condition will undergo a 4 to 8 week health education series, with a parallel protocol as the MBSR intervention. Monitoring of adherence will be same as above. | Other: Health Education<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure during dialysis |  | 8 weeks | 
| Cardiopulmonary baroreflex Sensitivity |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney Disease Quality of Life (KDQOL) Symptom Score |  | 8 weeks |