Mechanisms of Intradialytic Hypertension (MID-H)

Emory University

Status: Completed

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

Treatments: Other: Mindfulness Meditation; Other: Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01947673

00025948 (Other Identifier)

IRB00066932

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups, including a placebo group

Modified Mindfulness Based Stress Reduction (MBSR) Program

Experimental group

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.

Treatment:

Other: Mindfulness Meditation

Health Education

Placebo Comparator group

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.

Treatment:

Other: Health Education