Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients

Kidney Failure, Chronic Clinical Trial

Official title:

Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01674660
• Other study ID #: BeijingCYH
• Secondary ID: 19860805
• Status: Not yet recruiting
• Phase: N/A
• First received: August 21, 2012
• Last updated: August 29, 2012
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2012
• Source: Beijing Chao Yang Hospital
• Contact: Cui TG Taigen, Dr.
• Phone: 010-85231510
• Email: fujine_521[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years to 85 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Locations

Country	Name	City	State
China	Nephrology, dialysis center,Beijing Chaoyang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	44 hours	Yes