Mechanisms of Intradialytic Hypertension (MID-H)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Collaborator:
Satellite Healthcare
Information provided by (Responsible Party):
Jeanie Park, Emory University
ClinicalTrials.gov Identifier:
NCT01947673
First received: September 18, 2013
Last updated: May 14, 2014
Last verified: May 2014

September 18, 2013
May 14, 2014
September 2013
August 2017   (final data collection date for primary outcome measure)
  • Blood Pressure during dialysis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Cardiopulmonary baroreflex Sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01947673 on ClinicalTrials.gov Archive Site
KDQOL Symptom Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Renal Failure Chronic Requiring Hemodialysis
  • Haemodialysis-induced Symptom
  • Hypertension
  • Other: Mindfulness Meditation
  • Other: Health Education
  • Experimental: Mindfulness Meditation
    During the first session, the MM instructor will meet with the participant during HD to provide instruction on mindfulness meditation, explain study procedures, and directly observe the participant listening to an audio recording of MM on an MP3 player with headphones. Thereafter, the participant will perform meditation by following a series of MM recordings during the first half of each hemodialysis session 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. Rather than meeting with the MM instructor, control participants will meet with a health educator and will listen to audio recordings of nutrition in ESRD during the first half of dialysis, and on non-dialysis days. 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
August 2017   (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.
Both
18 Years to 80 Years
No
United States
 
NCT01947673
IRB00066932, 00025948
No
Jeanie Park, Emory University
Emory University
Satellite Healthcare
Not Provided
Emory University
May 2014

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