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Completed

NCT Number: NCT03525223

Modulation of Tissue Sodium in Hemodialysis Patients

Salt (NaCl) intake is implicated in causing hypertension and cardiovascular disease, the commonest cause of death worldwide. The investigators recently established that Na+ is stored in tissues, bound to glycosaminoglycans (GAGs) in skin and muscle. The resulting local hypertonicity leads to immune cell-driven induction of local tissue electrolyte clearance via modulation of cutaneous lymph capillary density. To visualize these complex processes in man directly, the investigators established Na+ magnetic resonance imaging (23Na-MRI) and investigated Na+ stores in hemodialysis (HD) patients. Hemodialysis patients were sodium-"overloaded" and HD treatment lowered tissue Na+ stores in this study. The observed effects were highly variable and independent of Na+ or water removal from the body during a dialysis session. Tissue Na+ mobilization correlated with circulating vascular endothelial growth factor-C (VEGF-C). The investigators believe that excessive Na+ storage is a reversible condition and therefore susceptible for therapeutic interventions. The investigators hypothesize that lowering dialysate Na+ concentration may favorably affect accelerated tissue Na+ accumulation in hemodialysis patients. Besides, improved tissue Na+ storage, osmostress-induced as well as pro-inflammatory immune cell response should be affected by such a revised dialysis management.

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Key information

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nephrology Department, University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

About this study

To evaluate effects of moderate reduction of dialysate Na+ concentration on tissue Na+ content the investigators intend to recruit 40 hemodialysis patients, who will be offered a therapeutic change of their dialysate Na+ concentration. After detection of tissue Na+ content using 23Na-MRI technique, the applied dialysate [Na+] will be initially increased stepwise by 2 mmol/l per week from 138 to 142 mmol/l and maintained for a period of 5 weeks. After another 23Na-MRI measurement, dialysate [Na+] will then be lowered stepwise by 1-2 mmol/l per week to a minimum of 135 mmol/l, which will be also maintained for a period of 5 weeks followed by a final 23Na-MRI assessment.

Hypothesis: Reduction of dialysate Na+ concentration will decrease tissue sodium storage.

Additionally, the investigators will assess changes in body fluid distribution by bioimpedance spectroscopy. Furthermore, vascular compliance in response to the modulation of dialysate [Na+] and its correlation with tissue Na+ will be assessed. To investigate the immune response to tissue Na+ accumulation, the osmostress-induced as well as pro-inflammatory immune cell response of isolated monocytes will be quantified.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic Kidney Disease Stage 5D, hemodialysis performed for at least 6 months, three times hemodialysis per week, signed informed consent

Exclusion criteria

  • Pregnancy, severe heart failure (NYHA III - IV), severe liver disease (CHILD C), acute infection, pacemaker or other non-MRI suitable conditions, hyponatremia < 132 mmol/l

Treatment and study plan

Change of dialysate [Na+]

Procedure

Stepwise modulation of dialysate sodium concentration by 1-2 mmo/l per week

Primary outcomes

  1. Tissue sodium content

    Time frame: 14 weeks

    Tissue sodium content measured by 23Na MRI

Secondary outcomes

  1. Lymphangiogenic profile

    Time frame: 14 weeks

    Serum VEGF-C and sFLT4 levels will be determined

  2. Body fluid distribution (extracellular and intracellular water)

    Time frame: 14 weeks

    Change in body fluid distribution will be assessed by body composition monitor (bioimpedance spectroscopy)

  3. Pulse wave analysis and pulse wave velocity

    Time frame: 14 weeks

    Change in central arterial pressure wave form and pulse wave velocity will be analyzed by SphygmoCor

  4. Flow-mediated vasodilatation (FMD)

    Time frame: 14 weeks

    Measurement of vasodilatation and thereby arterial stiffness by a semi-automated ultrasound System (UNEXEF)

  5. Immune response to tissue Na+ accumulation

    Time frame: 14 weeks

    Blood monocytes will be isolated and their osmotic and inflammatory response will be determined

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Impact of Changes in Dialysis Sodium Concentration on Tissue Sodium Storage in Hemodialysis Patients

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 15, 2018
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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