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Chronic Kidney Disease Requiring Chronic DialysisNCT03525223

Modulation of Tissue Sodium in Hemodialysis Patients

A study testing Change of dialysate [Na+] in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Change of dialysate [Na+]
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteGermany
Study dates
15 May 2018to 6 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Nephrology Department, University Hospital Erlangen

    Erlangen, Bavaria, 91054

Other trials in Germany

About this study

Official title: Impact of Changes in Dialysis Sodium Concentration on Tissue Sodium Storage 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.

Read the detailed description

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.

Being tested
Change of dialysate [Na+]
Keywords
23Na MRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Change of dialysate [Na+]Procedure or surgery

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

Study groups in NCT03525223
Study groupRoleWhat they receive
dialysate [Na+] 138 mmol/lActive comparatorIntervention: Change of dialysate [Na+] from 138 mmol/l to 142 mmol/l The dialysate [Na+] will be increased by 2 mmol/l per week and kept constant for 5 weeks (altogether 6 weeks). Before and after intervention tissue [Na+] will be determined by sodium MRI. Additionally body fluid distribution (by bioimpedance spectroscopy) and central arterial pressure wave form, pulse wave velocity as well as flow-mediated vasodilatation will be assessed.
Receives: Procedure: Change of dialysate [Na+]
dialysate [Na+] 142 mmol/lActive comparatorIntervention: Change of dialysate [Na+] from 142 mmol/l to 135 mmol/l The dialysate [Na+] will be decreased by 2 mmol/l per week for 3 weeks and by 1mmol/l for 1 further week. Afterwards the dialysate [Na+] will be kept constant for 5 weeks (altogether 8 weeks). Before and after intervention tissue [Na+] will be determined by sodium MRI. Additionally body fluid distribution (by bioimpedance spectroscopy) and central arterial pressure wave form, pulse wave velocity as well as flow-mediated vasodilatation will be assessed.
Receives: Procedure: Change of dialysate [Na+]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tissue sodium content

    Tissue sodium content measured by 23Na MRI

    Measured: 14 weeks

Secondary outcomes (5)

  1. Lymphangiogenic profile

    Serum VEGF-C and sFLT4 levels will be determined

    Measured: 14 weeks

  2. Body fluid distribution (extracellular and intracellular water)

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

    Measured: 14 weeks

  3. Pulse wave analysis and pulse wave velocity

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

    Measured: 14 weeks

  4. Flow-mediated vasodilatation (FMD)

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

    Measured: 14 weeks

  5. Immune response to tissue Na+ accumulation

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

    Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2018
  2. Study start15 May 2018
  3. Primary completion6 Sep 2022
  4. Study completion6 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525223
Sponsor's protocol ID
DNa
Status last verified
Nov 2020
First submitted
24 Apr 2018
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dahlmann A, Dorfelt K, Eicher F, Linz P, Kopp C, Mossinger I, Horn S, Buschges-Seraphin B, Wabel P, Hammon M, Cavallaro A, Eckardt KU, Kotanko P, Levin NW, Johannes B, Uder M, Luft FC, Muller DN, Titze JM. Magnetic resonance-determined sodium removal from tissue stores in hemodialysis patients. Kidney Int. 2015 Feb;87(2):434-41. doi: 10.1038/ki.2014.269. Epub 2014 Aug 6.

    PubMed 25100048

  • Kopp C, Linz P, Maier C, Wabel P, Hammon M, Nagel AM, Rosenhauer D, Horn S, Uder M, Luft FC, Titze J, Dahlmann A. Elevated tissue sodium deposition in patients with type 2 diabetes on hemodialysis detected by 23Na magnetic resonance imaging. Kidney Int. 2018 May;93(5):1191-1197. doi: 10.1016/j.kint.2017.11.021. Epub 2018 Feb 15.

    PubMed 29455909

  • Titze J, Dahlmann A, Lerchl K, Kopp C, Rakova N, Schroder A, Luft FC. Spooky sodium balance. Kidney Int. 2014 Apr;85(4):759-67. doi: 10.1038/ki.2013.367. Epub 2013 Oct 9.

    PubMed 24107854

Questions about this trial

What is this clinical trial studying?

A study testing Change of dialysate [Na+] in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tissue sodium content (time frame: 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03525223, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.

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