- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03261154
Serum iPTH, Calcium and Phosphate, and the Risk of Mortality in Beijing Elderly Hemodialysis Population
Incidence of End Stage Renal Disease (ESRD) amongst elderly patient group is continuously increasing with population aging progressing. Mineral and bone disorder (MBD) is a common complication caused by ESRD, it raises the incidence of cardiovascular disease (CVD) in hemodialysis patients, as well as mortality.
Joint effects of Kidney failure and aging on elderly hemodialysis patients make the contribution factors of CKD-MBD quite complex, and it also leads to differences in clinic manifestation between elderly hemodialysis patients and non-elderly hemodialysis patients. Since not much studies had been done for this specific subject, thus, research on elderly patients who is taking Maintenance hemodialysis is very necessary. This study is a retrospective research to identify optimized target value of Calcium and Phosphorus for elderly patients taking maintenance hemodialysis and hence provide guidance for clinical practices. The data for this study will be provided by Beijing Blood Purification Quality Control and Improvement Center. Clinical files and Calcium and Phosphorus metabolic indices will be collected amongst elderly patients who were elder than 65 years and was taking maintenance hemodialysis between Jan 1st, 2012 through Dec 31st, 2016. Relationship between Calcium level, Phosphorus level, iPTH index, all-cause mortality and CVD caused mortality will be analyzed to identify optimized range of target Calcium levels, Phosphorus level for hemodialysis treatment
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100050
- Beijing Friendship Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The data shall include the information of elderly hemodialysis patients who were 65 years or elder between Jan 1st, 2012 and Dec 31st, 2016
Exclusion Criteria:
- The patients who only has less than 6 months history of hemodialysis since selected in the research patient group The patients who passed away within 3 months since selected in the research patient group The patients who took less than 3 hemodialysis in a week The patients who took kidney transplant during the research time period The patients who do not have blood biochemical results in the records
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 5 years
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all patients died in our observation period
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CVD-related mortality
Time Frame: 5 years
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the cause of death was cardiovascular disease related
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-P2-126-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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