NCT05699447

Brief Summary

The goal of this retrospective observational cohort study is to analysis the 1-year mortality in older patients undergoing maintenance hemodialysis. The main question it aims to answer is to explore the risk factors affecting the mortality of older patients undergoing maintenance hemodialysis and establish a risk prediction score. Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC). Logistic regression model was used to evaluate the 1-year mortality and the influence of predictive factors. Internal validation of the model was performed using the bootstrap 1000 repeat sampling method. Area under receiver operating characteristic curve (AUC) was used to evaluate the predictive ability of the model.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

January 17, 2023

Last Update Submit

January 25, 2023

Conditions

Keywords

Older patientsmaintenance hemodialysismortalityrisk prediction score.

Outcome Measures

Primary Outcomes (1)

  • the 1-year mortality in older patients undergoing maintenance hemodialysis

    Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC).

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data of older patients (age ≥65 years old) undergoing maintenance hemodialysis were collected from 2012-1-December 31, 2014, with data from Beijing Blood Purification Quality Control and Improvement Center (BJHDQCIC).

You may qualify if:

  • Age ≥65 years.
  • More than 6-month history of hemodialysis,the frequency is 3 times a week, and the dialysis time is 4 hours each.
  • The dialysate Ca concentration was 1.5 mmol/L and the bicarbonate level was 32 -- 35 mmol/L.

You may not qualify if:

  • Lack of demographic information, clinical history, or relevant laboratory values (including pre-dialysis serum calcium, phosphorus, iPTH, haemoglobin, albumin, creatinine, total cholesterol, and Kt/v for urea).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

November 28, 2022

Primary Completion

January 10, 2023

Study Completion

January 16, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01