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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05699447
Other study ID # 2022-P2-385-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 28, 2022
Est. completion date January 16, 2023

Study information

Verified date January 2023
Source Beijing Friendship Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date January 16, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Friendship Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
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