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. 2016 Aug 9;2016(8):CD010741. doi: 10.1002/14651858.CD010741.pub2

Kim 2013.

Methods
  • Study design: RCT

  • Study duration: August 2011 to April 2012

  • Study follow‐up period: to postoperative day 7

Participants
  • Country: Republic of Korea

  • Setting: university teaching hospital

  • Relevant health status: adult live‐donor kidney transplant recipients

  • Number: treatment group (30); control group (30)

  • Mean age ± SD (years): treatment group (44 ± 12); control group (46 ± 12)

  • Sex (M/F): treatment group (17/13); control group (21/9)

  • Cold ischaemia time (minutes): treatment group (74 ± 16); control group (80 ± 20)

  • Warm ischaemia time (minutes): treatment group (35 ± 6); control group (36 ± 6)

  • Exclusion criteria: severe cardiovascular or respiratory disease

Interventions Treatment group
  • Plasma‐lyte®

    • Intraoperative IV fluid titrated to keep CVP at 12 to 15 mm Hg


Control group
  • Normal saline

    • Intraoperative IV fluid titrated to keep CVP at 12 to 15 mm Hg


Co‐intervention
  • 750 mL of intraoperative 5% albumin given to all participants


Post‐operative fluid
  • 0.45% saline with 5 mmol/L potassium chloride and 7 mmol/L bicarbonate


Baseline immunosuppression
  • Induction: basiliximab and methylprednisolone

  • Maintenance

    • Prednisolone

    • Cyclosporin or tacrolimus

    • Mycophenolic acid or mizoribine

Outcomes
  • Delayed graft function: requirement for dialysis within 7 days post‐transplant

  • Acid‐base status: mean difference in blood pH, serum chloride concentration, and serum bicarbonate concentration at the end of surgery compared to baseline

Notes
  • Funding source: no information on funding sources was provided

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "One day before transplant surgery, patients were assigned to either the NS group or the Plasmalyte group according to a random number sequence." Page 2192, paragraph 3
Allocation concealment (selection bias) Unclear risk Information on allocation concealment was not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "The study solutions were prepared in unlabeled bags by a staff nurse who was not involved in the study. Attending anesthesiologists and surgeons were blinded to group assignments." Page 2191, paragraph 3
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Specific information on masking of outcome and data assessors was not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No information on intention‐to‐treat principle or missing outcome date reported. However, there were no drop‐outs from the study
Selective reporting (reporting bias) Unclear risk No trial registration or published protocol
Other bias High risk All patients received intra‐operative albumin 5% as well as postoperative 0.45% normal saline with 5 mmol/L KCl and 7 mmol/L HCO3. This could lead to non‐differential misclassification error as the control group was also exposed to a balanced electrolyte solution. No information on funding reported