Mechanisms of Intradialytic Hypertension (MID-H)

Sympathetic Regulation in Intradialytic Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Renal Failure Chronic Requiring Hemodialysis; Haemodialysis-induced Symptom
• Intervention / Treatment: Other: Health Education; Other: Mindfulness Meditation

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Dialysis Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure during dialysis	8 weeks
Cardiopulmonary baroreflex Sensitivity	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Kidney Disease Quality of Life (KDQOL) Symptom Score	8 weeks

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Satellite Healthcare
• Investigators: Principal Investigator: Jeanie Park, MD, MS, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: September 18, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Hypertension; Kidney Failure, Chronic
• Other Study ID Numbers: IRB00066932; 00025948 (Other Identifier: Emory)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No