Trace Element Imbalances in Patients With Chronic Kidney Disease (CKD) Undergoing Dialysis: the Role of Hemodialysis Treatment as an Environmental Factor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Profile of circulating trace element levels
研究概览
简要总结
Chronic kidney disease (CKD) is associated with alterations in the balance of trace elements and metals, which may result from reduced dietary intake, impaired renal function, dialysis-related removal, or environmental exposure. Hemodialysis may play a relevant role in both the removal and potential introduction of these elements. This pilot study aims to investigate trace element and metal imbalances in older patients with advanced CKD and to assess the influence of bicarbonate hemodialysis and dialysis-related environmental exposure on their elemental profile.
详细描述
This is a prospective, observational, monocentric pilot study involving patients aged 60 years or older with advanced chronic kidney disease (CKD).
Participants will be divided into two groups: patients about to start bicarbonate hemodialysis (BIC-HD) and patients undergoing BIC-HD for at least 5 years, with at least 10 patients per group.
The study aims to assess blood levels of selected trace elements and metals, including zinc, copper, manganese, lead, aluminum, mercury, selenium, cadmium and chromium, before and after hemodialysis, and to investigate the potential influence of dialysis treatment and dialysis-related environmental exposure.
Blood and dialysate samples will be collected before and after dialysis, together with samples of the tap water used for the treatment. Samples will be analyzed using inductively coupled plasma mass spectrometry (ICP-MS) and inductively coupled plasma optical emission spectrometry (ICP-OES).
Clinical and laboratory data will also be collected to investigate the association between elemental imbalances and selected clinical manifestations, including cardiovascular and infectious events, anemia, peripheral neuropathy, cognitive impairment and malnutrition. Cognitive function will be assessed at baseline and after 6 months using the FACT-Cog questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 60 years or older;
- •Patients attending the Nephrology and Dialysis Unit (SCDU) of AOU AL;
- •Patients about to start hemodialysis (HD) using the bicarbonate dialysis (BIC-HD) technique (Group A patients) or patients already on dialysis for at least 5 years using the bicarbonate dialysis (BIC-HD) technique (Group B patients);
- •Patients with stage V or Vd chronic kidney disease (CKD);
- •Signature of informed consent.
排除标准
- •Patients with previous kidney transplants (resumption of dialysis treatment after the transplant period).
研究组 & 干预措施
Prevalent patients
Patients who have been receiving BIC-HD for at least 5 years. 10 patients will be enrolled in this group.
干预措施: Compare blood concentrations of selected trace elements and metals before and after hemodialysis (Other)
Incident patients
Patients with stage V/Vd CKD who are about to start bicarbonate hemodialysis (BIC-HD). 10 patients will be enrolled in this group.
干预措施: Compare blood concentrations of selected trace elements and metals before and after hemodialysis (Other)
结局指标
主要结局
Profile of circulating trace element levels
时间窗: Baseline, pre and post treatment and after 6 months
Comparison of blood levels of trace elements regarding deficiency and excess in the incident and prevalent patients groups, before and after dialysis treatment
次要结局
- Evaluation of the impact of hemodialysis treatment(Baseline and after 6 month)
- Association between baseline trace elements levels and clinical manifestations.(Baseline and after 6 month)
- Predictor of mortality(Baseline and after 6 month)
- FACT-Cog questionnaire.(Baseline and after 6 month)