CClinicalTrials.gg
CompletedNCT03261154Updated Aug 24, 2017

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

An observational study in End Stage Renal Disease, sponsored by Wenhu Liu. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-08-24.

Sponsored by Wenhu Liu · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1,000
Ages
65 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • End Stage Renal Disease

Keywords

  • Serum iPTH
  • Calcium
  • Phosphate
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1,000 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. All-cause mortality

    all patients died in our observation period

    Time frame: 5 years

Secondary outcomes

  1. CVD-related mortality

    the cause of death was cardiovascular disease related

    Time frame: 5 years

06

Study locations

1 site
  • Beijing Friendship hospital
    Beijing, Beijing 100050, China
07

Registry details

Key details

Study ID
NCT03261154
Lead sponsor
Wenhu Liu
Responsible party
Wenhu Liu (Director of Nephrology Deptartment, Beijing FH, Beijing Friendship Hospital) — Sponsor-investigator
First posted
Aug 24, 2017
Start date
Jan 1, 2012
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016
Last update
Aug 24, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion