Renal Failure Chronic Requiring HemodialysisMID-HNCT01947673
Mechanisms of Intradialytic Hypertension
A study testing Mindfulness Meditation and Health Education in people with Renal Failure Chronic Requiring Hemodialysis and Haemodialysis-induced Symptom, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure Chronic Requiring Hemodialysis, Haemodialysis-induced Symptom, Hypertension
- What is being tested?
- Mindfulness Meditation and Health Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ESRD patients on maintenance hemodialysis for at least 6 months, with increased blood pressure during hemodialysis
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Sympathetic Regulation in 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.
- Being tested
- Mindfulness Meditation, Health Education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationOther
Health EducationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure during dialysis
Measured: 8 weeks
Cardiopulmonary baroreflex Sensitivity
Measured: 8 weeks
Secondary outcomes (1)
Kidney Disease Quality of Life (KDQOL) Symptom Score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure Chronic Requiring HemodialysisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Satellite Healthcare
- Responsible party
- Principal investigator, Jeanie Park, Emory University
- Investigators
- Jeanie Park, MD, MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947673
- Sponsor's protocol ID
- IRB00066932
- Other IDs
- 00025948
- Acronym
- MID-H
- Status last verified
- Jul 2021
- First submitted
- 18 Sep 2013
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Regulation in Intradialytic Hypertension
- ClinicalTrials.gov ID
- NCT01947673
- Acronym / sponsor ID
- MID-H / IRB00066932
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Satellite Healthcare
- Study start
- Sep 2013 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Mindfulness Based Stress Reduction (MBSR) Program | Experimental | Other: Mindfulness MeditationAfter 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. |
| Health Education | Placebo comparator | Other: Health EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ESRD patients on maintenance hemodialysis for at least 6 months, with increased blood pressure during hemodialysis
Key exclusion criteria (12 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation | Other | Modified Mindfulness Based Stress Reduction (MBSR) Program |
| Health Education | Other | Health Education |
Primary outcome
Blood Pressure during dialysis
Time frame: 8 weeks
Cardiopulmonary baroreflex Sensitivity
Time frame: 8 weeks
1 secondary outcome
Kidney Disease Quality of Life (KDQOL) Symptom Score
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanie Park, MD, MS principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation and Health Education in people with Renal Failure Chronic Requiring Hemodialysis and Haemodialysis-induced Symptom, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure during dialysis (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.