NL-OMON21336招募中不适用
Potassium supplementation in patients with chronic kidney disease and healthy subjects: effects on potassium and sodium balance
AUMC - AMC0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult patients (= 18 years) with CKD 3b or 4 (45 – 15 ml/min/1.73 m2).
- •Hypertension (defined as office blood pressure > 140/90 mmHg and using RAAS inhibitor treatment).
- •Healthy subjects:
- •Healthy adults (= 18 years), as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination (PE) and laboratory tests carried out in the screening visit (V0).
- •Using no medication (excluding contraceptives).
排除标准
- •Hyperkalemia (serum potassium > 5.5 mmol/l).
- •Medical reasons to continue dual RAAS-blockade, mineralocorticoid receptor
- •blockers, potassium-sparing diuretics, or oral potassium binders.
- •Patients with previous history of ventricular cardiac arrhythmia.
- •Patients with diabetes mellitus.
- •Patients with a life expectancy < 6 months.
- •Expected initiation of renal replacement therapy < 6 months.
- •Incapacitated subjects.
- •Women who are pregnant, breastfeeding or consider pregnancy in the coming 6 months.
- •Healthy subjects:
- •Hyperkalemia (serum potassium > 5.5 mmol/l).
- •Women who are pregnant, breastfeeding or consider pregnancy in the coming 6 months.
- •An office blood pressure = 140/90 mmHg.
- •A body mass index = 30 kg/m2.
- •A major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavourable for enrolment, including diabetes mellitus.
- •A history of any type of malignancy within the past 5 years with the exception of successfully treated basal cell carcinoma of the skin.
- •A history of any renal disease.
- •A history of any blood clotting disorders.
- •A history of any auto-immune disease.
- •A history of cardiovascular disease (in the past 6 months) defined as documented coronary artery disease including myocardial infarction (MI), (un-)stable angina pectoris or acute coronary syndrome (ACS), percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG), cerebrovascular disease, including ischaemic and haemorrhagic stroke or a subarachnoid bleeding (SAB), or peripheral artery disease, including aortic aneurysmata (AA).
- •A history of ventricular cardiac arrhythmia.
- •Any significant sign or symptom of hypotension.
研究者
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