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

  • Duration of study: 29 January 1983 to 15 January 1984

  • Duration of follow‐up: 12 months

Participants
  • Country: Canada

  • Setting: multicentre (9 centres)

  • Donor characteristics

    • Mean age ± SD (years): MP group (38.0 ± 16); SCS group (29.7 ± 15)

    • Unclear as to whether the donors were DBD/DCD or SCD/ECD

    • Sex (M/F): not reported

    • Inclusion criteria: not reported

    • Exclusion criteria: not reported

  • Recipient characteristics

    • Inclusion criteria: not reported

    • Exclusion criteria: not reported

    • Sex (M/F): MP group 55/35; SCS group: 65/26

    • Mean age ± SD (years): MP group (38.1 ± 16); SCS group (38.7 ± 16)

Interventions Machine perfusion
  • Waters pulsatile perfusion machine using plasmate solution, except in 10 kidneys where the Gambro machine was used


Static cold storage
  • Collins' solution


Mean CIT
  • Although slightly higher in the MP group mean CIT did not differ significantly between the study arms: 27.7 ± 12 hours in the SCS group and 30.5 ± 10 hours in the MP group

Outcomes
  • DGF

  • Number of dialyses in the first week

  • Graft and patient 1‐year survival

  • Cause of graft failure

  • One week creatinine

Notes
  • This was not a paired study; each donor was randomised to have both kidneys machine perfused or both kidneys SCS

  • 107 donors. 2 recipients weren't followed up, 12 kidneys were discarded and 13 randomised to receive MP underwent SCS and were excluded. This left 181 kidneys (90 received SCS, and 91 received MP)

  • There are two manuscripts describing the same study, the more recent of the two (1987) is far more detailed

  • The study gives a complex definition for DGF. Data taken from the number of dialyses in the first week table can be used to find rates of DGF consistent with the current definition, allowing inclusion of this study in the meta analysis

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Low risk Patients were randomised before procurement, immediately after consent for organ donation
Blinding of participants and personnel (performance bias) All outcomes Low risk No blinding, but CIT was not statistically significantly different between groups
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 High risk 13 kidneys randomised to MP and were then changed to SCS. These patients were not reported and were excluded from the study; intention to treat analysis was not employed
Selective reporting (reporting bias) High risk They used a complex and unusual definition for DGF, for unclear reasons. However, data included in our analysis will be taken directly from the number of dialyses in week one table, so this bias will not impact on the meta analysis
Other bias Unclear risk A relatively short methods section