Clinical trial NCT06053866: Prevalence of Erythropoiesis Stimulating Agents Hyporesponsiveness in Dialysis Patients in Assiut University Hospital
Official title: Prevalence of Erthropoietin Stimulating Agents Hyporesponsiveness and Its Correlation With Cardiovascular Morbidities in Hemodialysis Patients in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Erythropoietin Resistant Anemia (EPO Resistant Anemia)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End stage renal disease patients undergoing regular hemodialysis for at least 3 months duration

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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the prevalence of Erythropoiesis stimulating agents hyporesponsiveness in dialysis patients in Assiut university hospital
timeFrame: One year
Secondary outcomes:
measure: Assessment of cardiovascular diseases risk in hemodialysis patients with erythropoiesis stimulating agents hyporesponsiveness
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hewida Abdelhakem Nafady
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Radwa Awad abdelhafez
role: STUDY_DIRECTOR
References:
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