NCT01947673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

4.2 years

First QC Date

September 18, 2013

Last Update Submit

July 12, 2021

Conditions

Renal Failure Chronic Requiring HemodialysisHaemodialysis-induced SymptomHypertension

Outcome Measures

Primary Outcomes (2)

  • Blood Pressure during dialysis

    8 weeks

  • Cardiopulmonary baroreflex Sensitivity

    8 weeks

Secondary Outcomes (1)

  • Kidney Disease Quality of Life (KDQOL) Symptom Score

    8 weeks

Study Arms (2)

Modified Mindfulness Based Stress Reduction (MBSR) Program

EXPERIMENTAL

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.

Other: Mindfulness Meditation

Health Education

PLACEBO COMPARATOR

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.

Other: Health Education

Interventions

Mindfulness MeditationOTHER
Modified Mindfulness Based Stress Reduction (MBSR) Program
Health EducationOTHER
Health Education

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ESRD patients on maintenance hemodialysis for at least 6 months, with increased blood pressure during hemodialysis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Dialysis Clinics

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jeanie Park, MD, MS

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 18, 2013

First Posted

September 20, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations

US(1)