Chronic kidney disease Chronic kidney disease
Conditions
Interventions
Sodium intake intervention
The participants in this group will receive 2 weeks high sodium diet 
(>
200mmol) and 2 weeks low sodium diet (<
50mmol). Between both diets, 
participants will have to at least 1 week washout period. 
Sodium excretion intervention
In a randomized crossover method, we will compare the effect of two sodium 
depleting antihypertensive drugs (hydrochlorothiazide, spironolactone) and a 
non-sodium depleting antihypertensive agent (lercarnidipine). This in order to 
determine whether tissue sodium content is dependent on systemic sodium 
overload, hypertension or both and to study the role of aldosteron in this 
proces. 
Water intake intervention
The participants in this group will receive a water intervention in which they 
drink their habitual water intake for 4 weeks and a high water intake (1L more 
than their mean 24-hour urine volume at screening and baseline) for 4 weeks. 
If the mean 24-hour urine volume at screening and baseline is >
1.5 L, the participant 
will be asked to drink <
1.5 L during the low water intake and >
2.5 L during the high water intake 
Between both water intakes, participants will have at least one week washout period.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Chronic kidney disease with an eGFR between 15 and 60 ml/min/1.73m2. 2. Stable diuretic and antihypertensive treatment in the 6 weeks prior to the study. Additional inclusion criteria for the sodium excretion intervention 1. Office systolic blood pressure (SBP) >135 mmHg Additional inclusion criteria for the water intake intervention 1. Chronic kidney disease with an eGFR between 15 and 29 ml/min/1.73m2 2. Office blood pressure >=140/90 mmHg or use of antihypertensive medication 3. Fasting morning urine osmolality <425 mOsm/kg for men and < 400 mOsm/kg for women
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Age <18 years. 2. The patient is expected to start renal replacement therapy or is planned to receive a kidney transplantation within 3 months 3. An active diagnosis of nephrotic syndrome at inclusion. 4. (Recurrent) acute glomerulonephritis within 1 year prior to the study. 5. Salt losing nephropathy. 6. Use of oral or intravenous glucocorticoids with an equivalent of prednisolone >5mg/day. 7. Contra-indication for MRI i.e. metallic foreign body, claustrofobia 8. Cardiovascular event or procedure during the previous 3 months. 9. Pregnant women, women of childbearing age planning to conceive for the study duration, women of childbearing age who do not use an effective contraception. 10. Participation in other intervention studies. 11. Presence of significant comorbidities (e.g. advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year. 12. A psychiatric, addictive or any disorder that compromises the participants’ ability to give truly informed consent for participation in this study. 13. Patients with an active infection and/or auto-immune diseases with involvement of the lower extremities. 14. Any other issues that in opinion of the investigator could be harmful to the subject or compromise interpretation of the data. Additional exclusion criteria for sodium intake intervention 1. Chronic use of NSAID Additional exclusion criteria for sodium excretion intervention 1. Serum potassium concentration >5.0 mmol/l. 2. eGFR <30 ml/min/1.73m2 3. Uncontrolled hypertension (>180/100mmHg) 4. Contra-indication for drugs used during this study e.g. drug intolerance (side effect, hyperkalaemia hypersensitivity to sulphonamides) and drug interaction. 5. Chronic use of NSAID. Additional exclusion criteria for the water intake intervention 1. Recent history of severe hyponatremia (outpatient plasma sodium < 130 mmol/L in the last 6 months) 2. Plasma sodium <135 mmol/L at screening 3. History of heart failure 4. Use of lithium, vasopressin analoga, vasopressin antagonists, oral or intravenous glucocorticoids. 5. Chronic use of NSAID
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort study: Incidence of cardiovascular events and renal replacement therapy. Sodium excretion intervention study: Skin sodium content difference between different treatments. Sodium intake intervention study: Skin sodium content difference between diets. Water intake intervention study: Skin sodium content and TEWL difference between low and high water intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort study: - The relation between tissue sodium content, changes in tissue sodium content, and micro- and macrovascular function. - The association between skin sodium content and traditional cardiovascular risk factors. - The association between skin sodium content and quality of life. Water intake intervention - The effect of water intake on blood pressure, copeptin, systemic vascular resistance and microcirculation. - Safety of increased water intake in CKD patients. | — |
Countries
Netherlands
Contacts
Public ContactR.H.G. Olde Engberink
Amsterdam UMC
Outcome results
None listed