This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Mechanisms of Intradialytic Hypertension (MID-H)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Jeanie Park, 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 6, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
Official Title: Sympathetic Regulation in Intradialytic Hypertension

Further study details as provided by Jeanie Park, Emory University:

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

Secondary Outcome Measures:
  • KDQOL Symptom Score [ Time Frame: 8 weeks ]

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
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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Jeanie Park, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01947673     History of Changes
Other Study ID Numbers: IRB00066932
00025948 ( Other Identifier: Emory )
Study First Received: September 18, 2013
Last Updated: May 6, 2017

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

ClinicalTrials.gov processed this record on June 26, 2017