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

Not yet recruiting

• Conditions: Erythropoietin Resistant Anemia (EPO Resistant Anemia)

• Registration Number: NCT06053866
• Lead Sponsor: Assiut University

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

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 Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-26
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Study Start: 2024-02-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Assessment of cardiovascular diseases risk in hemodialysis patients with erythropoiesis stimulating agents hyporesponsiveness	One year	Echocardiography