Factors Influencing Hemoglobin Variability and Its Association With Mortality in Hemodialysis Patients

Completed

• Conditions: Hemodialysis-Induced Symptom

• Registration Number: NCT03454906
• Lead Sponsor: Baskent University

Brief Summary

The aim of the study is to investigate the factors influencing hemoglobin variability with inflammatory and nutritional parameters and its associations with all-cause mortality among hemodialysis patients.

Detailed Description

Fluctuation in hemoglobin levels that is known as hemoglobin variability during treatment with ESA is a well-documented phenomenon. Several factors have been found to affect hemoglobin variability, including drug related, such as pharmacokinetic parameters, patient-related differences in demographic characteristics and factors affecting clinical status, as well as clinical practice guidelines, treatment protocols and reimbursement policies. Inflammation is also an important factor associated with hemoglobin variability, and the consequences of persistent inflammatory activity are far-reaching in affected patients.

In present study, the factors influencing hemoglobin variability with inflammatory and nutritional parameters and its associations with all-cause mortality among hemodialysis patients are investigated.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Status Verified: 2018-02
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-27
• Last Update Submitted: 2018-02-27
• Study First Posted: 2018-03-06
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• Age >18
• on chronic hemodialysis treatment

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Exclusion Criteria

• All patients had a minimum of six hemoglobin measurements within a 6- month period, and they were excluded if they received a kidney transplant during this period or those who had blood transfusions during the baseline period.
• Patients with serum ferritin<100 μg/L were also excluded from the study because of reimbursement of our country.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Factors Influencing Hemoglobin Variability and Its Association with Mortality in Hemodialysis Patients	six month	investigation of factors influencing hemoglobin variability with inflammatory and nutritional parameters and the association of hemoglobin variability with all-cause mortality among hemodialysis patients