Kidney Failure, ChronicNCT01674660
Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients
An observational study of Kidney Failure, Chronic, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability. Read more about this study
- Who is it for?
- Ages 24 to 85 years
- Conditions the study is for
- Kidney Failure, Chronic
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Mar 2013
- Phase
- Observational
- 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 24 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hemodialysis patients of Beijing Chaoyang Hospital
Who may be able to join
- age 18 years or older
- receipt of thrice-weekly in-center hemodialysis
- no anticipation of imminent(<6 months)living related kidney transplant
- not transfer of care to a nonparticipating facility
- no dialytic modality change
- free of vascular, infectious, or bleeding complication within 1 month Exclusion Criteria:
Show all 10Show fewer
- who missed >2 hemodialysis treatments over 1 month
- abused drugs
- severe anemia，malnutrition，chronic atrial fibrillation
- body mass index of 40 >kg/m2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Nephrology, dialysis center,Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Ma WH Weihua, Master, 010-85231952, maweihua_521@sina.com
Cui TG taigen, Dr., 010-85231952, fujine_521@sina.com
About this study
The purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.
Read the detailed description
Hemodialysis patients experience higher rates of cardiovascular morbidity and mortality than the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. However, additional unidentified risk factors also likely contribute to the disproportionately high prevalence of cardiovascular morbidity in hemodialysis patients. Blood pressure variability may represent one plausible cardiovascular risk factor. Data from nonuremic human populations show an association between greater blood pressure variability and cardiovascular events,nonfatal cardiovascular events,stroke,and increased left ventricular mass. There has been comparatively little work examining the causes and effects of blood pressure variability in hemodialysis populations. So the purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.
- Conditions
- Kidney Failure, Chronic
- Keywords
- hemodialysis, blood pressure variability, volume status
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| volume status | volume status:group1 over volume status,group2 normal volume status,group3 low volume status | |
| night blood pressure | night blood pressure：group1 nondipper,group2 dipper,group3 extreme dipper,group4 riser | |
| interdialysis weight gain | interdialysis weight gain:group1 >5% dry weight,group2 <5% dry weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
interdialytic blood pressure
Ambulatory BP monitoring was performed after the midweek hemodialysis session for 44 hours. Ambulatory BPs were recorded every 20 minutes during the day (6 AM to 10 PM) and every 30 minutes during the night (10 PM to 6 AM) in the nonaccess arm, We use the coefficient of variation or standard deviation in interdialytic blood pressure as a indicator of systolic blood pressure variability.
Measured: 44 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Weihua, Beijing Chao Yang Hospital
- Investigators
- Ma WH weihua, Master, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674660
- Sponsor's protocol ID
- BeijingCYH
- Other IDs
- 19860805
- Status last verified
- Aug 2012
- First submitted
- 21 Aug 2012
- Last updated
- 31 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01674660
- Acronym / sponsor ID
- BeijingCYH
- Conditions
- Kidney Failure, Chronic
- Keywords
- hemodialysis, blood pressure variability, volume status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 29 Aug 2012 (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.
The purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.
Detailed description
Hemodialysis patients experience higher rates of cardiovascular morbidity and mortality than the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. However, additional unidentified risk factors also likely contribute to the disproportionately high prevalence of cardiovascular morbidity in hemodialysis patients. Blood pressure variability may represent one plausible cardiovascular risk factor. Data from nonuremic human populations show an association between greater blood pressure variability and cardiovascular events,nonfatal cardiovascular events,stroke,and increased left ventricular mass. There has been comparatively little work examining the causes and effects of blood pressure variability in hemodialysis populations. So the purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| volume status | – | –volume status:group1 over volume status,group2 normal volume status,group3 low volume status |
| night blood pressure | – | –night blood pressure：group1 nondipper,group2 dipper,group3 extreme dipper,group4 riser |
| interdialysis weight gain | – | –interdialysis weight gain:group1 >5% dry weight,group2 <5% dry weight |
Who may qualify
- Ages
- 24 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hemodialysis patients of Beijing Chaoyang Hospital
Key inclusion criteria (10 listed)
- age 18 years or older
- receipt of thrice-weekly in-center hemodialysis
- no anticipation of imminent(<6 months)living related kidney transplant
- not transfer of care to a nonparticipating facility
- no dialytic modality change
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
interdialytic blood pressure
Time frame: 44 hours
Ambulatory BP monitoring was performed after the midweek hemodialysis session for 44 hours. Ambulatory BPs were recorded every 20 minutes during the day (6 AM to 10 PM) and every 30 minutes during the night (10 PM to 6 AM) in the nonaccess arm, We use the coefficient of variation or standard deviation in interdialytic blood pressure as a indicator of systolic blood pressure variability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
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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.
Ma WH weihua, Master principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic, run by Beijing Chao Yang Hospital at 1 site in China.
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 10 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 31 Aug 2012. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cui TG Taigen, Dr. (010-85231510, fujine_521@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interdialytic blood pressure (time frame: 44 hours). 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 31 Aug 2012.