Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients

August 29, 2012 updated by: Ma Weihua, Beijing Chao Yang Hospital
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 Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Nephrology, dialysis center,Beijing Chaoyang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hemodialysis patients of Beijing Chaoyang Hospital

Description

Inclusion Criteria:

  • 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:
  • who missed >2 hemodialysis treatments over 1 month
  • abused drugs
  • severe anemia，malnutrition，chronic atrial fibrillation
  • body mass index of 40 >kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
44 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Principal Investigator: Ma WH weihua, Master, Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

August 31, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingCYH
  • 19860805 (Registry Identifier: Ma Weihua)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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