Skip to main content
. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Leski 1979.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 4 weeks

  • Time frame: not reported

Participants Study characteristics
  • Setting: single centre

  • Country: Switzerland

  • Inclusion criteria: HD patients

  • Exclusion criteria: not reported


Baseline characteristics
  • Number (analysed/randomised): overall (not reported/10)

  • Mean age ± SD (years): overall (53.1 ± 9.0)

  • Sex (M/F): overall (5/5)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): overall (3.2 ± 2.3)

  • Comorbidities

    • CVD: not reported

    • Diabetes: not reported

    • Hypertension: not reported

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Pharmacological intervention

  • Indication: study targeting fatigue


Intervention group
  • Dialysis sessions with dialysate containing glucose 400 mg/100 mL


Control group
  • Dialysis sessions with dialysate of the same composition but without glucose


Co‐interventions
  • Every patient had 3 dialysis sessions/week

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

  • Fatigue

    • Questionnaire (evaluated on a 3‐point system, 0, +, + +): assessed post dialysis

    • Glycaemia: assessed in all samples during the study period

  • Immunoreactive insulin: measured in 44/120 sessions

  • BP: monitoring during the study period

  • Body weight: monitoring during the study period

  • Headache

    • Questionnaire (evaluated on a 3‐point system, 0, +, + +): assessed during and after dialysis

  • Leg cramps

    • Questionnaire (evaluated on a 3‐point system, 0, +, + +): assessed during and after dialysis

  • Adverse events (hypotension): assessed until the end of treatment

  • Laboratory results (cholesterol, triglycerides, BUN, plasma creatinine, sodium, potassium): assessed pre and post dialysis

Notes Additional information
  • Funding: not reported

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not applicable

  • A priori published protocol: not reported

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 Quote: "Each patient was interrogated in a standardized fashion by the same person (Th. N.) during each dialysis concerning the preceding one. [...] The questionnaire was evaluated on a three‐point system, 0, +, + +, headache during and after dialysis, fatigue and leg cramps."
Comment: The outcomes were assessed with an appropriate measure, without differences between groups. 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. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias)
All outcomes High risk The number of patients who completed the study was not clearly stated. It was unclear if there was evidence that the results were not biased by missing outcome data
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were not reported. It was not reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue at the end of treatment was not reported in a format that was 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