The role of skin sodium accumulation in chronic kidney disease

Conditions: Chronic kidney disease
10029149

Registration Number: NL-OMON53426

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

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

Exclusion Criteria

Exclusion criteria
1. Age <18 years.
2. An eGFR decline >5 ml/min/1.73m2 per year.
3. Proteinuria >3 grams/day.
4. Use of glucocorticoids with an equivalent of prednisolone >5mg/day
5. Use of or a calcineurin inhibitor.
6. Contra-indication for MRI i.e. metallic foreign body, claustrofobia
7. Cardiovascular event in the 3 months prior to the study
8. Patients with active infection and/or auto-immune diseases with involvement
of the lower extremities.
9. Presence of significant comorbidities (e.g. advanced malignancy, advanced
liver disease) with a life expectancy of less than 1 year.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cohort study:<br /><br>Incidence of cardiovascular events and renal replacement therapy.<br /><br><br /><br>Sodium excretion intervention study:<br /><br>Skin sodium content difference between different treatments.<br /><br><br /><br>Sodium intake intervention study:<br /><br>Skin sodium content difference between diets.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cohort study:<br /><br>- The relation between tissue sodium content, changes in tissue sodium content,<br /><br>and micro- and macrovascular function.<br /><br>- The association between skin sodium content and traditional cardiovascular<br /><br>risk factors.<br /><br>- The association between skin sodium content and quality of life.</p><br>