Mechanisms of Intradialytic Hypertension

NCT ID: NCT01947673

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness Meditation

Intervention Type: OTHER

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.

Group Type: PLACEBO_COMPARATOR

Health Education

Intervention Type: OTHER

Interventions

Mindfulness Meditation

Intervention Type: OTHER

Health Education

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satellite Healthcare

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Jeanie Park

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanie Park, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Dialysis Clinics

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

00025948

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00066932

Identifier Type: -

Identifier Source: org_study_id