NCT01674660

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 21, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

August 21, 2012

Last Update Submit

August 29, 2012

Conditions

Keywords

hemodialysisblood pressure variabilityvolume status

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age24 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hemodialysis patients of Beijing Chaoyang Hospital

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology, dialysis center,Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, urine.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ma WH weihua, Master

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cui TG Taigen, Dr.

CONTACT

Ma WH Weihua, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigater

Study Record Dates

First Submitted

August 21, 2012

First Posted

August 29, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations