Serum iPTH, Calcium and Phosphate, and the Risk of Mortality in Beijing Elderly Hemodialysis Population

August 23, 2017 updated by: Wenhu Liu

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

Completed

Study Type

Observational

Enrollment (Actual)

1000

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

    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Friendship 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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 5 years
all patients died in our observation period
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CVD-related mortality
Time Frame: 5 years
the cause of death was cardiovascular disease related
5 years

Collaborators and Investigators

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

Sponsor

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 (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-P2-126-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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