Evidence map›Paper›PMID 29663430›Full record

Trial reportArtificial organs2018

Effectiveness of a New Single-Needle Single-Pump Dialysis System with Simultaneous Monitoring of Dialysis Dose.

Wolfgang Bieser, Markus Welsch, Marten Jakob, Jörn Meibaum, David A Rodriguez, Henrik Wolff, Daniele Marcelli, Claudia Barth

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Artificial organs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

  1. Efficiency comparison between new single-needle dialysis and conventional double-needle dialysis and exploration of the optimal prescription parameters for single-needle hemodialysis.Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2025
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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

8 authors.

Wolfgang BieserNephrologie, Medizinisches Versorgungszentrum Saarbrücken, Saarbrücken, Germany.
Markus WelschDialyse, Medizinisches Versorgungszentrum Saarbrücken, Saarbrücken, Germany.
Marten JakobDepartment of Medical Scientific Affairs, B. Braun Avitum AG, Melsungen, Germany.
Jörn MeibaumDepartment of Research and Development, B. Braun Avitum AG, Melsungen, Germany.
David A RodriguezDepartment of Research and Development, B. Braun Avitum AG, Melsungen, Germany.
Henrik WolffDepartment of Research and Development, B. Braun Avitum AG, Melsungen, Germany.
Daniele MarcelliDepartment of Medical Scientific Affairs, B. Braun Avitum AG, Melsungen, Germany.ORCID http://orcid.org/0000-0002-7650-8578
Claudia BarthDepartment of Medical Scientific Affairs, B. Braun Avitum AG, Melsungen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To date, single-needle (SN) hemodialysis (HD) requires a dialysis machine equipped with two blood pumps-one controlling arterial blood flow (Qb) and one controlling venous Qb. B. Braun has developed an innovative single-pump SN HD system. Therefore, usability is improved by reducing complexity. The aim of this study was to compare dialysis parameters of the new single-pump SN HD system with a double-pump SN HD system available on the market (Fresenius Medical Care [FMC] 5008). In this two-armed crossover study, patients were randomized into two groups (B. Braun - FMC/FMC - B. Braun). Study period was 2 weeks (6 HD sessions) for each SN HD system. Both B. Braun and FMC dialysis machines were operated in the single-needle auto mode. With the FMC dialysis machines, Qb was optimized manually, whereas for B. Braun machines it was optimized automatically using the auto-mode functionality. A phase volume of 25 mL, treatment time, needle type and size, and dialyzer type and size were kept constant per patient throughout the study. Due to technical prerequisites in the SN mode, online dialysis adequacy (Kt/V: K - dialyzer clearance of urea; t - dialysis time; V - volume of distribution of urea) monitoring could only be performed in the B. Braun group. Twelve HD patients (5 male/7 female, mean age 75.5 ± 8.8 years, mean time on dialysis 4.97 ± 3.86 years, 3× weekly HD) were enrolled. Total number of treatments performed: n = 132 (65 B. Braun, 67 FMC) and the mean online Kt/V value in the B. Braun group was 1.26 ± 0.29 (n = 63). Mean dialysis time per session: B. Braun 253.4 ± 19.9 min, FMC 251.6 ± 18.8 min. Mean phase volume: B. Braun 25.1 ± 0.2 mL, FMC 25.4 ± 3.1 mL. Mean cumulated blood volume (CBV): B. Braun 55.0 ± 5.5 L, FMC 40.5 ± 5.9 L (P < 0.0001). Mean Qb: B. Braun 217.8 ± 12.9 mL/min, FMC 178.6 ± 14.9 mL/min (effective Qb) (P < 0.0001), which corresponds to a difference of 39.3 mL/min (22.0%). Higher Qb has an influence on the CBV. To evaluate this effect, CBV was corrected for the difference in Qb by calculating the CBV/Qb rate. The mean CBV/Qb rate was 252.2 ± 19.4 min (B. Braun) and 226.8 ± 27.6 min (FMC) (P < 0.0001) per session. This represents a highly significant difference of 11.4%. To support the in vivo data the dead time for opening/closure of the clamps of the FMC 5008 was measured, resulting in 364 milliseconds. Over a 240 min dialysis session, with a blood flow rate of 250 mL/min and a phase volume of 25 mL, it was estimated at about 14.56 min (6.1% of the session). Similarly, it was estimated that the dead time of the pumps of the FMC 5008 during 240 min dialysis session was 4.7 min (1.9% of the session). In case single needle therapy is the only practical option for a patient, the advantages of the new single-pump single needle system-namely the proven higher cumulative blood volume, the alarm-free auto-regulation of the blood flow and the easier handling for the nursing staff-ensure higher treatment efficiency than conventional double-pump single needle systems.

Indexed as

Arteriovenous Shunt, SurgicalKidney DiseasesKidneys, ArtificialRenal DialysisAdultAgedCatheterizationCross-Over StudiesEquipment DesignFemaleHemodynamicsHumansMaleMiddle AgedNeedlesRegional Blood Flow-Cannulation complication-Dialysis adequacySingle-needle hemodialysis-Vascular access

Identifiers

PMID29663430
PMCPMC6174946

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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.