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. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

VENOUS 2020.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 12 months

  • Time frame: not reported

Participants Study characteristics
  • Setting: not reported

  • Country: Japan

  • Inclusion criteria: dialysis patients > 70 years

  • Exclusion criteria: hypoalbuminaemia as less than 3.0 g/dL; history of cardiovascular events 3 months prior to the entry; independence; > 90 years


Baseline characteristics
  • Number (analysed/randomised): intervention group (15/28); control group (14/26)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Dialysis type: not reported

  • Dialysis vintage (years) (mean ± SD): not reported

  • Comorbidities

    • CVD: intervention group (0/28); control group (0/26)

    • Diabetes: not reported

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Pharmacological intervention

  • Indication: study reporting fatigue


Intervention group
  • Anti‐thrombotic polymethyl‐methacrylate membrane


Control group
  • Placebo


Co‐interventions
  • Not reported

Outcomes Outcomes reported
  • Fatigue outcome measures used: validation data available

  • Nutritional status

    • Malnutrition inflammation score: every 3 months, up to 12 months

  • Normalised protein catabolic rate: every 3 months, up to 12 months

  • Creatinine generation rate: every 3 months, up to 12 months

  • Patients symptoms as a QoL (arthralgia, skin itchiness, irritable sense, fatigue, headache, dialysis‐related hypotension, leg cramps, and post‐dialytic bed‐free time): every 3 months, up to 12 months

Notes Additional information
  • Funding: not reported

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not reported

  • A priori published protocol: not reported

  • Abstract

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation methods were not reported in sufficient detail to permit judgement
Allocation concealment (selection bias) Unclear risk Method of allocation concealment was not reported in sufficient detail to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported. However, interventions were different and participants and/or investigators could be aware of the treatment assigned
Blinding of outcome assessment (detection bias)
All outcomes High risk It was unclear if fatigue was assessed with an appropriate measure. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. Other subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "11 patients in the NF group and 10 patients in the PS group were dropped out from the study. The reasons of the discontinuation were hypoalbuminaemia (1), increased bete‐2 microglobulin, social reasons (2), dead (1), unknown reason (5) in NF group, and modality change (2), unknown reason (8). Finally, 15 patients in NF and 14 patients terminated the study, however, 2 patients with the data deficit in each group were excluded."
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were not reported. Fatigue was reported in a format that was not extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias Unclear risk No data were available to assess the possible imbalance between groups. Funding and conflicts of interest were not reported