Mechanisms of Intradialytic Hypertension (MID-H)
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ClinicalTrials.gov Identifier: NCT01947673 |
Recruitment Status :
Completed
First Posted : September 20, 2013
Last Update Posted : July 15, 2021
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Condition or disease | Intervention/treatment | Phase |
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Renal Failure Chronic Requiring Hemodialysis Haemodialysis-induced Symptom Hypertension | Other: Mindfulness Meditation Other: Health Education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 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 |
Actual Primary Completion Date : | November 2017 |
Actual Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
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Experimental: Modified Mindfulness Based Stress Reduction (MBSR) Program
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.
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Other: Mindfulness Meditation |
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 |
- Blood Pressure during dialysis [ Time Frame: 8 weeks ]
- Cardiopulmonary baroreflex Sensitivity [ Time Frame: 8 weeks ]
- Kidney Disease Quality of Life (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: | No |
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

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
United States, Georgia | |
Emory Dialysis Clinics | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Jeanie Park, MD, MS | Emory University |
Responsible Party: | Jeanie Park, Assistant Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT01947673 |
Other Study ID Numbers: |
IRB00066932 00025948 ( Other Identifier: Emory ) |
First Posted: | September 20, 2013 Key Record Dates |
Last Update Posted: | July 15, 2021 |
Last Verified: | July 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Failure, Chronic Hypertension Vascular Diseases Cardiovascular Diseases |
Renal Insufficiency Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic |