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NCT01947673 Clinical Trial

Mechanisms of Intradialytic Hypertension

Hypertension Clinical Trial

— MID-H  

Official title:
Sympathetic Regulation in Intradialytic Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01947673
Other study ID # IRB00066932
Secondary ID 00025948
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date November 2017

Study information
Verified date July 2021
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Mindfulness Meditation

• Health Education

Locations
Country Name City State
United States Emory Dialysis Clinics Atlanta Georgia

Sponsors (2)
Lead Sponsor Collaborator
Emory University Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood Pressure during dialysis 8 weeks
Primary Cardiopulmonary baroreflex Sensitivity 8 weeks
Secondary Kidney Disease Quality of Life (KDQOL) Symptom Score 8 weeks
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