Prevalence of Erythropoiesis Stimulating Agents Hyporesponsiveness in Dialysis Patients in Assiut University Hospital

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06053866
Collaborator
(none)
240
17

Study Details

Study Description

Brief Summary

  • The prevalence of erthropoietin stimulating agents hyporesponsiveness in hemodialysis patients in Assiut university hospital

  • Assessment of cardiovascular diseases risk in patients with erythropoiesis stimulating agents hyporesponsiveness in hemodialysis patients in Assiut university hospital

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Anemia is common in patients with chronic kidney disease. The routine use of erthropoietin in anemia control has reduced morbidity and mortality rates in patients with chronic kidney disease. Despite an increase in the use and average dose of recombinant human epoetin over the last 15 years, a substantial percentage of patients still don't achieve hemoglobin targets recommend by international guidelines. The definition of recombinant human epoetin resistance has been introduced to identify those patients in whom the target hemoglobin level is not attained despite a greater than usual dose of erthropoietin stimulating agent. In recent years, increasing attention has been paid to the relationship between dialysis, increased inflammatory stimulus, malnutrition, and erythropoiesis stimulating agents response. Erythropoiesis stimulating agents hyporesponsiveness was defined by the erythropoietin resistance index, which was the erythropoietin dose per week divided by body weight and Hemoglobin level . The resistance to erythropoiesis stimulating agents is directly related with incident comorbidity in patients on hemodialysis and it can be interpreted as a useful marker of early mortality. Patients with higher erythropoietin resistance index values had a higher all cause mortality rate and cardiovascular mortality rate. Erythropoietin resistance index was related with left ventricular mass index, left ventricle systolic function and cardiovascular events in patients with hemodialysis. By monitoring of erthropoietin resistance index, early identification of the epoetin resistance may be useful to predict the cardiovascular risk in hemodialysis patients

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Prevalence of Erthropoietin Stimulating Agents Hyporesponsiveness and Its Correlation With Cardiovascular Morbidities in Hemodialysis Patients in Assiut University Hospital
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of the prevalence of Erythropoiesis stimulating agents hyporesponsiveness in dialysis patients in Assiut university hospital [One year]

      Erythropoiesis resistance index which is the erythropoietin dose per week divided by body weight and Hemoglobin level

    Secondary Outcome Measures

    1. Assessment of cardiovascular diseases risk in hemodialysis patients with erythropoiesis stimulating agents hyporesponsiveness [One year]

      Echocardiography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • age more than 18

    • End stage renal disease patients undergoing regular hemodialysis in Assiut University Hospital - Hemodialysis unit for duration at least 3 months

    Exclusion Criteria:
    • acute infectious disease within one month

    • active liver disease or cancer

    • recent blood transfusion or surgical intervention

    • active bleeding or hemorrhage

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Hewida Abdelhakem Nafady, Assiut University
    • Study Director: Radwa Awad abdelhafez, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Feby Rasmy Khalifa Makar, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06053866
    Other Study ID Numbers:
    • Erythropoietin resistance
    First Posted:
    Sep 26, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 26, 2023