The Role of Skin Sodium Accumulation in Chronic Kidney Disease
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
60 participants
Jan 7, 2025
INTERVENTIONAL
Conditions
Summary
This project consists of four substudies: a cohort study (A) and a sodium intake intervention (B) and a sodium excretion intervention (C) and a water intervention study (D). The main objective of the cohort study (A) is to investigate the prognostic implications of tissue sodium accumulation in CKD patients. The primary objective of the sodium intervention studies is to study the effect of high and low sodium intake (B) and increased renal sodium excretion (C) on tissue sodium content. The main objective of the water intervention study (D) is to investigate the effect of increased and habitual water intake on tissue sodium content and transepidermal water loss.
Eligibility
Inclusion Criteria5
- Chronic kidney disease with an eGFR between 15 and 60 ml/min/1.73m2.
- Stable diuretic and antihypertensive treatment for the previous 6 weeks.
- Chronic kidney disease with an eGFR between 15 and 29 ml/min/1.73m2
- Office blood pressure ≥140/90 mmHg or use of antihypertensive medication
- Fasting morning urine osmolality \<425 mOsm/kg for men and \< 400 mOsm/kg for women
Exclusion Criteria31
- Age \<18 years.
- The patient is expected to start renal replacement therapy or is planned to receive a kidney transplantation within 3 months.
- An active diagnosis of nephrotic syndrome at inclusion.
- (Recurrent) acute glomerulonephritis within 1 year prior to the study.
- Salt losing nephropathy.
- Use of oral or intravenous glucocorticoids with an equivalent of prednisolone \>5mg/day.
- Contra-indication for MRI.
- Cardiovascular event/ surgery in the previous 3 months.
- Pregnant women, women of child bearing age planning to conceive for the study duration, women of child bearing age without contraception.
- Participation in other (pharmacological) intervention studies.
- Presence of significant comorbidities with a life expectancy of less than 1 year.
- Disorder that compromises the participants' ability to give truly informed consent for participation in this study.
- Patients with an active infection and/or auto-immune diseases with involvement of the lower extremities.
- Any other issues that in opinion of the investigator could be harmful to the subject or compromise interpretation of the data.
- \. Chronic use of NSAID
- Serum potassium concentration \>5.0 mmol/l.
- eGFR \<30 ml/min/1.73m2
- Uncontrolled hypertension (\>180/100 mmHg)
- Severe heart failure with left ventricular ejection fraction \<30%.
- Contra-indication for investigational drugs.
- Severe symptoms of (orthostatic) hypotension.
- Patients with obstruction of the outflow tract of the left ventricle such as aortic valve stenosis.
- Refractory hypokalemia, hyponatremia or hypercalcemia.
- Severe liver insufficiency Child Pugh B/C
- Chronic use of NSAID.
- Recent history of severe hyponatremia (outpatient plasma sodium \< 130 mmol/L in the last 6 months)
- Plasma sodium \<135 mmol/L at screening
- History of heart failure
- Use of lithium, vasopressin analoga, vasopressin antagonists, oral or intravenous glucocorticoids, thiazide diuretics.
- hour urine volume \> 2L
- Chronic use of NSAID
Interventions
Each patient will receive 1 tablet of hydrochlorothiazide 12.5mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dosage is doubled to 2 tablets of hydrochlorothiazide 12.5mg once daily for the following 3 weeks. If the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.
Each patient will receive 1 tablet of spironolacton 12.5mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dose is doubled to 2 tablets of spironolacton 12.5mg once daily for the following 3 weeks. If the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.
Each patients will receive 1 tablet of lercanidipine 10mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dose is doubled to 2 tablets of lercanidipine 10mg once daily for the following 3 weeks. If the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.
The patients will receive a 2-week high sodium diet. The patients will receive dietary advice to achieve this goal of \>200mmol/l sodium (\>12g salt) intake per day.
The patients will receive a 2-week low sodium diet. The patients will receive dietary advice to achieve this goal of \<50mmol/l sodium (\<3g salt) intake per day.
During the increased water intake period, the patients will be instructed to drink 1 L more than their mean 24-hour urine volume at screening and baseline.
During this part of the intervention, the patients will be instructed to maintain their habitual water intake.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07020104