Development and testing of an algorithm by a clinical pharmacist for optimization of erythropoietin and iron dosing for correcting anemia in patients undergoing hemodialysis (Proof of Concept): An Interventional Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- To develop and test a clinical pharmacist–managed dosing algorithm for optimizing erythropoietin and iron therapy to correct and maintain hemoglobin within the target range (10–11.5 g/dL) in patients undergoing hemodialysis.
研究概览
简要总结
This study aims to evaluate the effectiveness of a clinical pharmacist managed dosing algorithm for erythropoietin and iron sucrose therapy in patients undergoing hemodialysis. Anemia is a common complication in chronic kidney disease that can reduce quality of life and increase health risks. The study will use a structured algorithm based approach to optimize erythropoietin and iron dosing, improve hemoglobin levels, and maintain iron parameters within the recommended range. It will be conducted as a single arm prospective interventional trial with baseline monthly follow ups and a final assessment at six months. The results are expected to provide evidence for improved anemia management through pharmacist led interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults equal to and above 18 years of age.
- •2.Patients with Chronic Kidney Disease (CKD) on maintenance hemodialysis.
- •3.Patients diagnosed with anemia and receiving erythropoietin therapy (with or without iron supplementation).
- •4.Clinically stable patients able to comply with study procedures.
- •5.Patients who provide written informed consent.
排除标准
- •1.Pregnant or lactating women.
- •2.Patients with active bleeding disorders or recent (within 3 months) major blood transfusion.
- •3.Patients with uncontrolled hypertension or severe cardiovascular instability.
- •4.Patients with active infection, malignancy, or other comorbidities likely to interfere with anaemia management.
- •5.Patients with known hypersensitivity to erythropoietin or iron preparations.
结局指标
主要结局
To develop and test a clinical pharmacist–managed dosing algorithm for optimizing erythropoietin and iron therapy to correct and maintain hemoglobin within the target range (10–11.5 g/dL) in patients undergoing hemodialysis.
时间窗: Baseline (pre-intervention) and monthly follow-ups for 6 months.
次要结局
- To evaluate the effect of the pharmacist-managed algorithm on erythropoietin dose requirements compared with baseline prescribing.(Baseline, monthly follow-ups, and final assessment at 6 months.)
- To assess changes in iron parameters (serum ferritin, transferrin saturation) following algorithm-based interventions.(Baseline, monthly follow-ups, and final assessment at 6 months.)
- To determine the proportion of patients requiring red blood cell transfusions before and after algorithm implementation.(Baseline, monthly follow-ups, and final assessment at 6 months.)
- To assess the safety of the algorithm by monitoring adverse drug reactions, iron overload, and rapid hemoglobin rises.(Baseline, monthly follow-ups, and final assessment at 6 months.)
- To evaluate the acceptance rate of pharmacist recommendations by nephrologists.(Baseline, monthly follow-ups, and final assessment at 6 months.)
- To assess the feasibility of implementing the dosing algorithm in a hemodialysis setting (recruitment rate, retention, time per patient review).(Baseline, monthly follow-ups, and final assessment at 6 months.)
研究者
Samarth R Anigol
KLE College of Pharmacy Belagavi