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

Sponsor
Baskent University (Other)
Overall Status
Completed
CT.gov ID
NCT03454906
Collaborator
(none)
169
Enrollment
13
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    169 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Baskent University Nephrology Department
    Actual Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2010
    Actual Study Completion Date :
    Feb 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    L Hemoglobin

    L Hemoglobin: consistently low all 6 months with low hemoglobin levels
    T Hemoglobin

    T Hemoglobin; consistently within the target range all 6 months with target-range hemoglobin levels
    H Hemoglobin

    H Hemoglobin: consistently high all 6 months with high hemoglobin levels
    LAL Hemoglobin

    LAL Hemoglobin: low amplitude fluctuation with low hemoglobin; all 6 months with low or target range hemoglobin levels
    LAH Hemoglobin

    LAH Hemoglobin: low-amplitude fluctuation with high hemoglobin levels 6 months with target-range or high hemoglobin levels)
    HA Hemoglobin

    HA Hemoglobin ; high-amplitude fluctuation low, target-range, and high hemoglobin levels within the 6 month period

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age >18

    • on chronic hemodialysis treatment

    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Baskent University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeynep Bal, Baskent University Nephrology Department, Baskent University
    ClinicalTrials.gov Identifier:
    NCT03454906
    Other Study ID Numbers:
    • KA09/358
    First Posted:
    Mar 6, 2018
    Last Update Posted:
    Mar 6, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zeynep Bal, Baskent University Nephrology Department, Baskent University
    hemodialysis
    hemoglobin variability
    mortality
    nutrition
    inflammation

    Study Results

    No Results Posted as of Mar 6, 2018