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MID-H: Mechanisms of Intradialytic Hypertension

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT01947673
Collaborator
Satellite Healthcare (Other)
49
Enrollment
1
Location
2
Arms
50
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Mindfulness Meditation
  • Other: Health Education
 N/A

Study Design

Study Type:
Interventional
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 :
Sep 1, 2013
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

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

Primary Outcome Measures

  1. Blood Pressure during dialysis [8 weeks]

  2. Cardiopulmonary baroreflex Sensitivity [8 weeks]

Secondary Outcome Measures

  1. Kidney Disease Quality of Life (KDQOL) Symptom Score [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Emory Dialysis Clinics Atlanta Georgia United States 30322

Sponsors and Collaborators

  • Emory University
  • Satellite Healthcare

Investigators

  • Principal Investigator: Jeanie Park, MD, MS, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeanie Park, Assistant Professor, Emory University
ClinicalTrials.gov Identifier:
NCT01947673
Other Study ID Numbers:
  • IRB00066932
  • 00025948
First Posted:
Sep 20, 2013
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Failure, Chronic
Hypertension

Study Results

No Results Posted as of Jul 15, 2021