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

O'Malley 2005.

Methods
  • Study design: RCT

  • Study duration: not reported

  • Study follow‐up period: 6 months

Participants
  • Country: USA

  • Setting: university teaching hospitals

  • Relevant health status: adult living and deceased‐donor kidney transplant recipients

  • Number: treatment group (25); control group (26)

  • Mean age ± SD (years): treatment group (44 ± 11); control group (44 ± 13)

  • Sex (M/F): treatment group (15/10); control group (17/9)

  • Donor type (living/deceased): treatment group (23/2); control group (25/1)

  • Cold ischaemia time (minutes): not reported

  • Warm ischaemia time (minutes): treatment group (34 ± 9); control group (34 ± 13)

  • Exclusion criteria: age < 18 years, religious prohibition of receipt of blood products, serum potassium level > 5.5 mEq/L before surgery

Interventions Treatment group
  • Lactated ringers

    • Intraoperative fluid only

    • Volume and rate at discretion of clinician


Control group
  • Normal saline

    • Intraoperative fluid only

    • Volume and rate at discretion of clinician


Post‐operative fluid
  • 5% dextrose with 0.45% saline

  • 0.45% saline with 20 mEq bicarbonate


Baseline immunosuppression
  • Induction: not reported

  • Maintenance

    • Tapering steroids

    • Calcineurin inhibitor

    • Mycophenolate mofetil or sirolimus

Outcomes
  • Clinically significant hyperkalaemia: serum potassium concentration > 6.0 mEq/L

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

  • Adverse events

    • Graft loss defined as requirement for dialysis (timeframe not specified): treatment group (1); control group (2)

    • Biopsy proven acute rejection: treatment group (2); control group (4)

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 "Randomization was achieved by computer generation of random number lists..." Page 1519, paragraph 2
Allocation concealment (selection bias) Low risk "Randomization was achieved by computer generation of random number lists, in blocks of four, and a closed envelope technique." Page 1519, paragraph 2
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk "The investigational pharmacy completely covered each bag of study fluid with opaque tape to ensure blinding of all study personnel and clinicians to the fluid type." Page 1520, paragraph 1
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 High risk The intention‐to‐treat principle was not adhered to. 54 patients were randomised and data from 51 patients were analysed. 3 patients were excluded after randomisation due to preoperative hyperkalaemia. Page 1520, paragraph 7
Selective reporting (reporting bias) Unclear risk No trial registration or published protocol
Other bias High risk All patients received 5% dextrose/0.45% normal saline with 20 mEq/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