O'Malley 2005.
Methods |
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Participants |
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Interventions | Treatment group
Control group
Post‐operative fluid
Baseline immunosuppression
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Outcomes |
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Notes |
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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 |