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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01947673
Recruitment Status : Recruiting
First Posted : September 20, 2013
Last Update Posted : September 28, 2017
Satellite Healthcare
Information provided by (Responsible Party):
Jeanie Park, Emory University

September 18, 2013
September 20, 2013
September 28, 2017
September 2013
August 2018   (Final data collection date for primary outcome measure)
  • Blood Pressure during dialysis [ Time Frame: 8 weeks ]
  • Cardiopulmonary baroreflex Sensitivity [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT01947673 on Archive Site
KDQOL Symptom Score [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
Mechanisms of Intradialytic Hypertension
Sympathetic Regulation in Intradialytic Hypertension
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Renal Failure Chronic Requiring Hemodialysis
  • Haemodialysis-induced Symptom
  • Hypertension
  • Other: Mindfulness Meditation
  • Other: Health Education
  • 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.
    Intervention: 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.
    Intervention: Other: Health Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2018
August 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
United States
00025948 ( Other Identifier: Emory )
Not Provided
Not Provided
Jeanie Park, Emory University
Emory University
Satellite Healthcare
Not Provided
Emory University
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP