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. 2019 Mar 15;2019(3):CD011671. doi: 10.1002/14651858.CD011671.pub2
Methods
  • Study design: parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 18.3 ± 2.7 months

Participants
  • Country: Netherlands

  • Setting: multicentre

  • Donor characteristics

    • Mean age ± SD: 36.6 ± 5.4 years

    • Number of DCD: all 38 (76 kidneys)

    • Sex (M/F): not reported

    • Inclusion criteria: all consecutive DCD donors

    • Exclusion criteria: not reported

  • Recipient characteristics

    • Inclusion criteria: not reported

    • Exclusion criteria: not reported

    • Sex (M/F): not reported

    • Mean age ± SD (years): not given but there were "no significant differences" between the SCS and MP groups

Interventions Machine perfusion
  • Gambro pulsatile perfusion machine using Belzer's solution


Static cold storage
  • UW solution


Mean CIT
  • Longer in the MP groups, but this was not statistically significant: 23.0 ± 1.3 hours in the SCS group and 25.0 ± 1.0 hours in the MP group

Outcomes
  • DGF

  • One‐year graft survival

  • SCr at 3 months

Notes
  • One kidney from each pair assigned to MP and the other to SCS

  • 76 kidneys from 38 consecutive donors. All were DCD donors

  • 5 patients were lost to follow up, and data for their DGF rate was not reported. Although not stated, further patients must have been lost to follow up before 1 year, as only percentages are given for graft survival, and these do not result in integers for the numbers of grafts lost, if all of the 71 recipients were followed up. This prohibits survival data from being used in the meta analysis

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Paired design with one kidney randomly assigned to each group. No information on how or at what stage the randomisation was done
Allocation concealment (selection bias) Unclear risk Too little information was given to allow assessment of allocation concealment
Blinding of participants and personnel (performance bias) All outcomes Low risk No blinding, but the difference in CIT between the arms was not statistically significantly different
Blinding of outcome assessment (detection bias) All outcomes Low risk No blinding, but outcome measurements are unlikely to be affected by the lack of blinding
Incomplete outcome data (attrition bias) All outcomes Unclear risk 5/76 lost to follow‐up, with no information on DGF. No explanation given for the patients lost to follow up, but similar numbers lost from each group
Selective reporting (reporting bias) Low risk Appropriate outcome measures, with each reported in the results section
Other bias Unclear risk Very concise materials and methods section so difficult to assess level of bias