N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- hemoglobin (gm%)
研究概览
简要总结
Anemia is a common comorbidity of CKD and is associated with a decreased quality of life and increased healthcare resource utilization. Anemia increases the risk of CKD progression, cardiovascular complications, and overall mortality. The current standard of care includes oral or intravenous iron supplementation, erythropoiesis-stimulating agents, and red blood cell transfusion. Treatment with high doses of erythropoiesis-stimulating agents increases rates of hospitalization, cardiovascular events, and mortality. Resistance to erythropoiesis-stimulating agents is a therapeutic challenge in many patients .
NAC reduces the risk of progression of CKD of any etiology to end stage renal disease (ESRD) but the mechanism by which it reduces the progression of CKD to ESRD is unclear. It may be because of its antioxidant and vasodilatory nature. Prolonged duration of administration and higher dosage of NAC can protect kidneys.
详细描述
All patients with chronic kidney disease on regular hemodialysis will be enrolled.
- Study location: The patients will be recruited from pediatric nephrology department, Cairo University Children's Hospital and Beni Suef University.
History taking including the age, sex, primary cause of CKD, onset of hemodialysis, medications including erythropoietin dose, frequency, and duration, oral or intravenous iron therapy, and frequency of blood transfusion.
Clinical examination focusing on pallor, blood pressure, and anthropometric measurements and their percentile.
Investigations including hemoglobin level at the start of the study and every month during the study period, serum ferritin, alanine aminotransferase, total oxidative stress (TOS), total antioxidant capacity (TAC), and oxidative stress index (OSI) at the start and after 3 months of the onset of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients with chronic kidney diseases stage 3, 4 or 5
排除标准
- •Unwilling to participate in the study.
- •non-compliant patients on the standard care of CKD.
- •Patients with cardiac, endocrinal, and hepatic complications.
- •Asthma or known allergy to NAC.
- •Any chronic infections prior to or during the study period.
研究组 & 干预措施
after treatment
chronic kidney disease patients after receiving NAC for 3 months
干预措施: N-acetyl cysteine (Drug)
结局指标
主要结局
hemoglobin (gm%)
时间窗: 3 months
the change in levels of hemoglobin after treatment
oxidative status
时间窗: 3 months
rate of change of total oxidative status after treatment using ELISA kits
left ventricular function
时间窗: 3 months
rate of change of left ventricular functions before and after treatment by electrocardiography
serum Ferritin level (mg/dl)
时间窗: 3 months
the change in levels of d ferritin after treatment using specific kits
Anti-oxidative status
时间窗: 3 months
rate of change of anti oxidant capacity after treatment
次要结局
- serious side effects(3 months)
研究者
Heba Mostafa Ahmed
Assistant professor
Beni-Suef University