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Completed

NCT Number: NCT01947673

Mechanisms of Intradialytic Hypertension

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.

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Key information

Conditions

Renal Failure Chronic Requiring Hemodialysis Cardiovascular Diseases Haemodialysis-induced Symptom Hypertension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Dialysis Clinics

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness meditation

Other

Health education

Other

Primary outcomes

  1. Blood Pressure during dialysis

    Time frame: 8 weeks

  2. Cardiopulmonary baroreflex Sensitivity

    Time frame: 8 weeks

Secondary outcomes

  1. Kidney Disease Quality of Life (KDQOL) Symptom Score

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Satellite Healthcare

Registry information

Official study title

Sympathetic Regulation in Intradialytic Hypertension

Acronym: MID-H

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2013
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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