Mechanisms of Intradialytic Hypertension (MID-H)
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| ClinicalTrials.gov Identifier: NCT01947673 |
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Recruitment Status :
Recruiting
First Posted : September 20, 2013
Last Update Posted : October 5, 2018
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Sponsor:
Emory University
Collaborator:
Satellite Healthcare
Information provided by (Responsible Party):
Jeanie Park, Emory University
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Renal Failure Chronic Requiring Hemodialysis Haemodialysis-induced Symptom Hypertension | Other: Mindfulness Meditation Other: Health Education | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Sympathetic Regulation in Intradialytic Hypertension |
| Actual Study Start Date : | September 2013 |
| Estimated Primary Completion Date : | August 2020 |
| Estimated Study Completion Date : | August 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Hypertension
MedlinePlus related topics:
Dialysis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Mindfulness Meditation
After individual instruction, participants in this arm will perform meditation by following a series of 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 the MP3 player at home on non-dialysis days, and asked to keep a log of these sessions.
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Other: Mindfulness Meditation |
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Placebo Comparator: Health Education
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.
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Other: Health Education |
Primary Outcome Measures :
- Blood Pressure during dialysis [ Time Frame: 8 weeks ]
- Cardiopulmonary baroreflex Sensitivity [ Time Frame: 8 weeks ]
Secondary Outcome Measures :
- KDQOL Symptom Score [ Time Frame: 8 weeks ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 MAO inhibitors
- peripheral neuropathy
- autonomic dysfunction
- pregnancy
- surgery within the past 3 months.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947673
Locations
| United States, Georgia | |
| Emory Dialysis Clinics | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Dana DaCosta 404-727-7762 drdacos@emory.edu | |
Sponsors and Collaborators
Emory University
Satellite Healthcare
| Responsible Party: | Jeanie Park, Assistant Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT01947673 History of Changes |
| Other Study ID Numbers: |
IRB00066932 00025948 ( Other Identifier: Emory ) |
| First Posted: | September 20, 2013 Key Record Dates |
| Last Update Posted: | October 5, 2018 |
| Last Verified: | October 2018 |
Additional relevant MeSH terms:
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Hypertension Renal Insufficiency Kidney Failure, Chronic Vascular Diseases |
Cardiovascular Diseases Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic |