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Mechanisms of Intradialytic Hypertension (MID-H)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01947673
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : July 15, 2021
Sponsor:
Collaborator:
Satellite Healthcare
Information provided by (Responsible Party):
Jeanie Park, Emory University

Study Description
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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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 Other: Health Education


Outcome Measures
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Primary Outcome Measures :
  1. Blood Pressure during dialysis [ Time Frame: 8 weeks ]
  2. Cardiopulmonary baroreflex Sensitivity [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Kidney Disease Quality of Life (KDQOL) Symptom Score [ Time Frame: 8 weeks ]

Eligibility Criteria
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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
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 monoamine oxidase (MAO) inhibitors
  • peripheral neuropathy
  • autonomic dysfunction
  • pregnancy
  • surgery within the past 3 months
Contacts and Locations
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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
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United States, Georgia
Emory Dialysis Clinics
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Satellite Healthcare
Investigators
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Principal Investigator: Jeanie Park, MD, MS Emory University
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic