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

van der Sande 2001.

Methods
  • Study design: cross‐over RCT

  • Follow‐up period: 4 weeks

  • Duration of study: not reported

Participants
  • Country: Netherlands

  • Setting: single centre

  • Inclusion criteria: not reported

  • Enrolled: 12

  • Mean age ± SD: 56.67 ± 15.95 years

  • Sex (M/F): 7/5

  • Exclusion criteria: not reported

Interventions Treatment arms
  1. Standard temperature HD (37.5°C)

  2. Cool‐temperature HD (35.5°C)

  3. Postdilution HDF with a low amount of replacement fluid (exchange volume, 1 L/h) with the temperature of 37.5°C

  4. HDF with an intermediate amount of replacement fluid (exchange volume, 2.5 L/h) with the temperature of 37.5°C

Outcomes
  • Maximum decline in MAP

  • Lowest body temperature during dialysis

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 Study was described as randomised; 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 Unclear risk Insufficient information to permit judgement: No description about the first phase data including missing values
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement: 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