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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: 22 months.

Participants
  • Country: Illinois, USA

  • Setting: multicentre

  • Mean age ± SD (years) Donor: 26.5 (3‐61)

  • Donor characteristics

    • Number of DCD: 0

    • Sex (M/F); not reported

    • Inclusion criteria: DBD donors with two kidneys suitable for transplant. "Criteria for donor selection was uniform for all participants"

    • Exclusion criteria: not reported

  • Recipient characteristics

    • Inclusion criteria: not reported

    • Exclusion criteria: not reported

    • Sex (M/F): "There were no significant differences between the groups with respect to recipient characteristics such as sex". Numbers of males in each group not reported

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

Interventions Machine perfusion
  • Waters MOX‐100 pulsatile perfusion machine using silica gel plasma perfusate


Static cold storage
  • Euro‐Collin's solution.


Mean CIT
  • Mean CIT was longer in the MP group although this was not significant (P = 0.09): 32.7 in the SCS group versus 35.2 in the MP group

Outcomes
  • DGF (called post‐transplant ATN in the study but defined as requirement for dialysis in the first week)

  • One‐year graft and patient survival

  • 90 day creatinine

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

  • 192 kidneys from 96 donors. However only 187 (94 SCS and 93 MP) kidneys were included in the study. All donors were DBD donors

  • Significantly more kidneys in the MP group had CIT >36 hours, compared to the SCS group (P = 0.01).

  • In the SCS group, the rate of DGF increased as CIT increased, whereas in the MP group rate of DGF was independent of CIT

  • 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) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) All outcomes High risk Recipient centres were informed of the preservation method used and left MP kidneys for longer; more kidneys had a CIT > 36 hours in the MP group (P = 0.01)
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 Low risk The 5 kidneys not used were as a result of "recipient unavailability" which is unlikely to be a source of bias. Thorough outcome data was reported for the remaining 187 patients
Selective reporting (reporting bias) Low risk Appropriate outcome measures, well reported
Other bias Unclear risk Limited methods section, as expected due to the date of the study