Evaluation of Hepatic Affection in Hemodialysis Patients With Iron Overload in Assiut University Hospital

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT05028595
Collaborator
(none)
80
1
23.3
3.4

Study Details

Study Description

Brief Summary

Aim of the work

  1. Assessment of hepatic affection in patients with ESRD (end stage renal disease) on regular dialysis with iron indices suggesting iron overload.

  2. Comparison between HCV -negative HD patients with high and normal TSAT as regard liver iron concentration(LIC) and degree of fibrosis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Anemia is a common complication in patients with chronic kidney disease (CKD) . The main cause of anemia is the inadequate production of erythropoietin. Iron deficiency is another common cause of anemia in these patients . Inflammation is another hallmark of CKD that may lead to a "functional" iron deficient anemia .

    The first treatment used to correct anemia in CKD patients was blood transfusion. However, the risk of transfusion reaction, transmission of infectious agents and iron overload triggered the search for a better treatment of anemia .

    Nowadays, the gold standard treatment for anemia in CKD patients is the administration of erythropoiesis stimulating agents (ESAs), associated with iron supplementation . Although the majority of the patients respond to ESA therapy, about 10% of CKD patients are hypo-responsive . One of the causes for hypo-responsiveness to ESAs is iron deficiency, either absolute or functional . A ferritin value lower than 30 ng/mL in men or lower than 15 ng/mL in women are consistent with absolute iron deficiency ; a serum ferritin concentration higher than 300 ng/mL, along with anemia, indicates a functional iron deficiency, as it usually occurs in CKD patients .

    The "Clinical Practice Guideline for Anemia in Chronic Kidney Disease" from KDIGO stated that CKD patients with anemia should first start iron therapy rather than ESAs .

    The Dialysis Outcomes and Practice Patterns Study (DOPPS) showed that the number of HD patients with IV iron supplementation increased in most countries and the doses prescribed to these patients also increased in the past 10-15 years.

    The liver is the main site of iron storage, and the liver iron concentration (LIC) is closely correlated with total body iron stores in patients with secondary forms of hemosiderosis such as thalassemia major, sickle cell disease, and genetic hemochromatosis . Non-invasive techniques for estimating liver iron stores have been developed to avoid liver biopsy, including the superconducting quantum interference device (SQUID), quantitative computed tomography, and MRI .

    More than one study show that 84% of the HD patients had hepatic iron overload, and in 30% of them iron overload was severe; moreover, iron liver content correlated with infused iron .

    In spite of the widespread use of IV iron supplementation in HD patients, the safest dosing strategy is still poorly clarified, as well as its relation with serum ferritin levels, iron overload and mortality risk.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of Hepatic Affection in Hemodialysis Patients With Iron Overload in Assiut University Hospital
    Actual Study Start Date :
    Jan 20, 2019
    Actual Primary Completion Date :
    Jan 30, 2020
    Actual Study Completion Date :
    Dec 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of hepatic affection in patients with ESRD (end stage renal disease) on regular dialysis with iron indices suggesting iron overload. [Baseline]

      MRI for abdomen was done .patient on supine position and multiple cuts were taken

    Secondary Outcome Measures

    1. Comparison between HCV -negative HD patients with high and normal TSAT as regard liver iron concentration(LIC) and degree of fibrosis. [Baseline]

      Assesment of degree of hepatic fibrosis by fibroscan machine ,Patients on supine position and sonar probe placed between ribs9-11 to asses degree of fibrosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Eighty patients with end-stage kidney disease (ESKD) on regular hemodialysis for more than two years were enrolled in the study with normal serum ferritin level at the start of dialysis
    Exclusion Criteria:
    • Patients with one or more of the following conditions were excluded; non-dialysis-dependent chronic kidney disease patients (NDD-CKD), iron deficiency anaemia (diagnosed based on iron studies included serum iron, ferritin and total iron binding capacity), other causes of hemochromatosis such as genetic type, or hemochromatosis secondary to hemolytic anemia, hepatitis B virus infection, and human immunodeficiency virus infection. Moreover, patients with additional causes of liver disease, including non-alcoholic fatty liver disease, primary sclerosing cholangitis, primary biliary cholangitis, etc. were excluded.

    Other exclusion criteria included active malignancy, heart failure, use of immunosuppressive drugs, previous liver transplantation, and patients who are below 18 year of age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marwa Abokresha Assuit Egypt 71511

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marwa M.Abokresha, principle investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05028595
    Other Study ID Numbers:
    • Hepatic MRI
    First Posted:
    Aug 31, 2021
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Aug 1, 2021
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 31, 2021