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Mechanisms of Intradialytic Hypertension (MID-H)

Primary Purpose

Renal Failure Chronic Requiring Hemodialysis, Haemodialysis-induced Symptom, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Meditation
Health Education
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Failure Chronic Requiring Hemodialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Dialysis Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Modified Mindfulness Based Stress Reduction (MBSR) Program

Health Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood Pressure during dialysis
Cardiopulmonary baroreflex Sensitivity

Secondary Outcome Measures

Kidney Disease Quality of Life (KDQOL) Symptom Score

Full Information

First Posted
September 18, 2013
Last Updated
July 12, 2021
Sponsor
Emory University
Collaborators
Satellite Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01947673
Brief Title
Mechanisms of Intradialytic Hypertension
Acronym
MID-H
Official Title
Sympathetic Regulation in Intradialytic Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Satellite Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic Requiring Hemodialysis, Haemodialysis-induced Symptom, Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Mindfulness Based Stress Reduction (MBSR) Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Mindfulness Meditation
Intervention Type
Other
Intervention Name(s)
Health Education
Primary Outcome Measure Information:
Title
Blood Pressure during dialysis
Time Frame
8 weeks
Title
Cardiopulmonary baroreflex Sensitivity
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Kidney Disease Quality of Life (KDQOL) Symptom Score
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 monoamine oxidase (MAO) inhibitors peripheral neuropathy autonomic dysfunction pregnancy surgery within the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanie Park, MD, MS
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Dialysis Clinics
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Mechanisms of Intradialytic Hypertension

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