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Mechanisms of Intradialytic Hypertension (MID-H)

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ClinicalTrials.gov Identifier: NCT01947673
Recruitment Status : Recruiting
First Posted : September 20, 2013
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
Satellite Healthcare
Information provided by (Responsible Party):
Jeanie Park, Emory University

Tracking Information
First Submitted Date  ICMJE September 18, 2013
First Posted Date  ICMJE September 20, 2013
Last Update Posted Date October 5, 2018
Actual Study Start Date  ICMJE September 2013
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
  • Blood Pressure during dialysis [ Time Frame: 8 weeks ]
  • Cardiopulmonary baroreflex Sensitivity [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01947673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
KDQOL Symptom Score [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanisms of Intradialytic Hypertension
Official Title  ICMJE Sympathetic Regulation in Intradialytic Hypertension
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Renal Failure Chronic Requiring Hemodialysis
  • Haemodialysis-induced Symptom
  • Hypertension
Intervention  ICMJE
  • Other: Mindfulness Meditation
  • Other: Health Education
Study Arms  ICMJE
  • 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.
    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. Monitoring of adherence will be same as above.
    Intervention: Other: Health Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01947673
Other Study ID Numbers  ICMJE IRB00066932
00025948 ( Other Identifier: Emory )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeanie Park, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Satellite Healthcare
Investigators  ICMJE Not Provided
PRS Account Emory University
Verification Date October 2018

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