Evidence map›Paper›PMID 30939213›Full record

Trial reportArtificial organs2019

Automated individualization of dialysate sodium concentration reduces intradialytic plasma sodium changes in hemodialysis.

Michaela Ságová, Ralf Wojke, Andreas Maierhofer, Malte Gross, Bernard Canaud, Adelheid Gauly

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Artificial organs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
4.6field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
  2. Article
  3. Medical device regulation and dialysis practice-impact on patients, doctors and manufacturers.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Sodium handling in pediatric patients on maintenance dialysis.Pediatric nephrology (Berlin, Germany) · 2023
    Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Michaela SágováFresenius Medical Care-DS, s.r.o, Prague 6, Czech Republic.
Ralf WojkeFresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.
Andreas MaierhoferFresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.
Malte GrossFaculty of Mechatronics and Medical Engineering, Ulm University of Applied Sciences, Ulm, Germany.ORCID https://orcid.org/0000-0002-7269-0077
Bernard CanaudFresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.
Adelheid GaulyFresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.ORCID https://orcid.org/0000-0002-2554-0711
Fresenius Medical Care (Germany) · DEFresenius Kabi (Czechia) · CZTechnische Hochschule Ulm · DE

Funding

Fresenius Medical Care Deutschland GmbH
6 · The paper itself

Abstract

In standard care, hemodialysis patients are often treated with a center-specific fixed dialysate sodium concentration, potentially resulting in diffusive sodium changes for patients with plasma sodium concentrations below or above this level. While diffusive sodium load may be associated with thirst and higher interdialytic weight gain, excessive diffusive sodium removal may cause intradialytic symptoms. In contrast, the new hemodialysis machine option "Na control" provides automated individualization of dialysate sodium during treatment with the aim to reduce such intradialytic sodium changes without the need to determine the plasma sodium concentration. This proof-of-principle study on sodium control was designed as a monocentric randomized controlled crossover trial: 32 patients with residual diuresis of ≤1000 mL/day were enrolled to be treated by high-volume post-dilution hemodiafiltration (HDF) for 2 weeks each with "Na control" (individually and automatically adjusted dialysate sodium concentration) versus "standard fixed Na" (fixed dialysate sodium 138 mmol/L), in randomized order. Pre- and post-dialytic plasma sodium concentrations were determined at bedside by direct potentiometry. The study hypothesis consisted of 2 components: the mean plasma sodium change between the start and end of the treatment being within ±1.0 mmol/L for sodium-controlled treatments, and a lower variability of the plasma sodium changes for "Na control" than for "standard fixed Na" treatments. Three hundred seventy-two treatments of 31 adult chronic hemodialysis patients (intention-to-treat population) were analyzed. The estimate for the mean plasma sodium change was -0.53 mmol/L (95% confidence interval: [-1.04; -0.02] mmol/L) for "Na control" treatments and -0.95 mmol/L (95% CI: [-1.76; -0.15] mmol/L) for "standard fixed Na" treatments. The standard deviation of the plasma sodium changes was 1.39 mmol/L for "Na control" versus 2.19 mmol/L for "standard fixed Na" treatments (P = 0.0004). Whereas the 95% CI for the estimate for the mean plasma sodium change during "Na control" treatments marginally overlapped the lower border of the predefined margin ±1.0 mmol/L, the variability of intradialytic plasma sodium changes was lower during "Na control" versus "standard fixed Na" treatments. Thus, automated dialysate sodium individualization by "Na control" approaches isonatremic dialysis in the clinical setting.

Indexed as

AgedAlgorithmsCross-Over StudiesDialysis SolutionsFemaleHumansKidney Failure, ChronicMaleMiddle AgedPrecision MedicineProspective StudiesRenal DialysisSodiumDialysis SolutionsSodiumautomated sodium adjustmentdialysis fluidhemodialysissodium

Identifiers

PMID30939213
PMCPMC6850400
OpenAlexW2935452227

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.