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Mechanisms of Intradialytic Hypertension

Sympathetic Regulation in Intradialytic Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01947673
Acronym
MID-H
Enrollment
49
Registered
2013-09-20
Start date
2013-09-30
Completion date
2017-11-30
Last updated
2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERMindfulness Meditation
OTHERHealth Education

Sponsors

Satellite Healthcare
CollaboratorOTHER
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Blood Pressure during dialysis8 weeks
Cardiopulmonary baroreflex Sensitivity8 weeks

Secondary

MeasureTime frame
Kidney Disease Quality of Life (KDQOL) Symptom Score8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026