Potassium supplementation in patients with chronic kidney disease and healthy subjects: effects on potassium and sodium balance

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Patients:
• 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 single
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).

Exclusion Criteria

Patients:
• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Serum potassium (in mmol/L). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Red Blood Cell (RBC) potassium (in mmol/L), renal potassium excretion, serum<br /><br>sodium, renal sodium excretion, total body water, and systolic blood pressure,<br /><br>as well as changes in serum bicarbonate, insulin, and plasma aldosterone. </p><br>