Evaluation of Hepatic Affection in Hemodialysis Patients With Iron Overload in Assiut University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of hepatic affection in patients with ESRD (end stage renal disease) on regular dialysis with iron indices suggesting iron overload.
研究概览
简要总结
Aim of the work
- Assessment of hepatic affection in patients with ESRD (end stage renal disease) on regular dialysis with iron indices suggesting iron overload.
- Comparison between HCV -negative HD patients with high and normal TSAT as regard liver iron concentration(LIC) and degree of fibrosis.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assessment of hepatic affection in patients with ESRD (end stage renal disease) on regular dialysis with iron indices suggesting iron overload.
时间窗: Baseline
MRI for abdomen was done .patient on supine position and multiple cuts were taken
次要结局
- Comparison between HCV -negative HD patients with high and normal TSAT as regard liver iron concentration(LIC) and degree of fibrosis.(Baseline)
研究者
Marwa M.Abokresha
principle investigator
Assiut University