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
  Purpose

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 Intervention
Renal Failure Chronic Requiring Hemodialysis
Haemodialysis-induced Symptom
Hypertension
Other: Mindfulness Meditation
Other: Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sympathetic Regulation in Intradialytic Hypertension

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • KDQOL Symptom Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other: Health Education

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 MAO inhibitors
  • peripheral neuropathy
  • autonomic dysfunction
  • pregnancy
  • surgery within the past 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jeanie Park, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01947673     History of Changes
Other Study ID Numbers: IRB00066932, 00025948
Study First Received: September 18, 2013
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Kidney Failure, Chronic
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 20, 2014