Raimann 2010.

Study characteristics
Methods	Study design Cross‐over RCT Study dates Duration of follow‐up: 3 weeks Time frame: April to June 2008
Participants	Study characteristics Setting: multicentre (2 dialysis centres of the Renal Research Institute in New York City) Country: USA Inclusion criteria: diabetic and nondiabetic patients in HD; ≥ 18 years; HD vintage > 30 days Exclusion criteria: receiving HD other than 3 times/week; history of infection, antibiotic treatment or hospitalisation during the preceding month Baseline characteristics Number (analysed/randomised): overall (29/29) Mean age ± SD (years): overall (54 ± 13) Sex (M/F): overall (15/14) Dialysis type: HD Mean dialysis vintage ± SD (years): overall (5 ± 4) Comorbidities CVD: not reported Diabetes: intervention group 1 (6/8); intervention group 2 (8/21) Hypertension: not reported Depression (clinician diagnosis): not reported
Interventions	Intervention classification Pharmacological intervention Indication: study targeting fatigue Intervention group 1 Dialysate glucose: 100 mg/dL Intervention group 2 Dialysate glucose: 200 mg/dL Co‐interventions No food was provided during the study treatments, and subjects were asked to refrain from eating
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available Laboratory results (potassium, phosphorous, glucose, insulin, HCT): measured at 0, 30, 60, 120, 180, 240 min Adverse events (including hypoglycaemia, cardiac arrhythmias): assessed at the end of treatment BP (especially SBP) OIscillometric method: measured at 0, 30, 60, 120, 180, 240 min ECG: assessed at each treatment Holter: assessed at each treatment Interdialytic weight gain Fatigue FSS (Appendix 3): after 3 weeks Motivation Exercise Physical functioning Duties and responsibilities Social life Subjective perception of fatigue
Notes	Additional information Funding: none Conflicts of interest/disclosures: J.A.D.‐B. is an employee of Fresenius Medical Care North America, P.K. and N.W.L. own stocks of Fresenius Medical Care (the author reported no conflicts of interest) Trial registration identification number: NCT00618033 A priori published protocol: approved by the Institutional Review Board of Beth Israel Medical Center, New York City, NY
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	Quote: "Chronic haemodialysis patients participated in this randomised, single masked, controlled crossover trial. [...] Throughout the entire study, patients were masked to dialysate glucose levels" Comment: A single‐blind study is considered as high risk of bias
Blinding of outcome assessment (detection bias) All outcomes	High risk	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	Low risk	All participants completed the study. No patients were loss to follow‐up
Selective reporting (reporting bias)	High risk	The study protocol was approved by the Institutional Review Board of Beth Israel Medical Center. 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 (cross‐over study: data related to the first period were not reported). 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. There was no funding and the authors did not have conflicts of interest