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. 2019 Jul 5;2019(7):CD012598. doi: 10.1002/14651858.CD012598.pub2

Levy 1992.

Methods
  • Study design: cross‐over RCT

  • Follow‐up period: 15 weeks

  • Duration of study: not reported

Participants
  • Country: USA

  • Setting: single centre

  • Inclusion criteria: clinically stable on chronic HD; high quality echocardiograms; in sinus rhythm

  • Enrolled: 6

  • Mean age ± SD: 55 ± 11 years

  • Sex (M/F): 6/0

  • Exclusion criteria: not reported

Interventions Treatment arm
  • Dialysate temperature of 35°C


Control arm
  • Dialysate temperature of 37°C

Outcomes
  • IDH rate

  • Mean BP at end of HD

Notes
  • Funding source: not reported

  • We requested further information but there was no response

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote "The dialysis procedures were performed in random order..."; method of randomisation was not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding was not feasible because of the nature of the intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No description about the first phase data including missing values but there were no dropouts
Selective reporting (reporting bias) Unclear risk The protocol was not available
Other bias High risk Carry‐over effects potentially existed. No description for the assessment of the baseline imbalance of first period of the cross‐over study