Mechanisms of Intradialytic Hypertension (MID-H)

• ClinicalTrials.gov Identifier: NCT01947673
• Recruitment Status: Completed
• First Posted: September 20, 2013
• Last Update Posted: July 15, 2021
• Sponsor: Emory University
• Collaborator: Satellite Healthcare
• Information provided by (Responsible Party): Jeanie Park, Emory University

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
Renal Failure Chronic Requiring Hemodialysis; Haemodialysis-induced Symptom; Hypertension	Other: Mindfulness Meditation; Other: Health Education	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: September 2013
• Actual Primary Completion Date: November 2017
• Actual Study Completion Date: November 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 [ Time Frame: 8 weeks ]
2. Cardiopulmonary baroreflex Sensitivity [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Georgia

Emory Dialysis Clinics

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Satellite Healthcare

Investigators

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

More Information

• Responsible Party: Jeanie Park, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT01947673
• Other Study ID Numbers: IRB00066932; 00025948 ( Other Identifier: Emory )
• First Posted: September 20, 2013
• Last Update Posted: July 15, 2021
• Last Verified: July 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; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic