Roberts 2010.
Methods | Randomised trial. | |
Participants | 16 critically ill patients (mean age range 30 to 41 years; 61% male) with known or suspected sepsis and normal renal function. Exclusion: not stated. |
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Interventions | Piperacillin‐tazobactam 4 g/0.5 g i.v. over 20 minutes, followed by 8 g/1 g continuous infusion over 24 h (piperacillin 333 mg/h) on day 1, then 12 g/1.5 g continuous infusion over 24 h (piperacillin 500 mg/h) vs piperacillin‐tazobactam 4 g/0.5 g i.v. q6h or q8h; mean treatment duration not stated. | |
Outcomes | Plasma‐concentration time profiles for first dose and steady state. Probability of target attainment by MIC against bacterial pathogens commonly encountered in critical care units. |
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Notes | Same data set as Roberts 2009c, with 3 additional patients (all met sepsis criteria). Will include only outcomes of interest for the 3 additional patients. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned "using random numbers selected from an opaque sealed envelope" (pg. 157); however, no sequence generation mentioned. |
Allocation concealment (selection bias) | Low risk | "Random numbers selected from an opaque sealed envelope" (pg. 157). |
Blinding (performance bias and detection bias) All outcomes | High risk | Open label. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reported mortality for all 16 randomly assigned participants (pg. 159, table 1). |
Selective reporting (reporting bias) | Unclear risk | No clinical trial protocol cited. |
Other bias | Unclear risk | Open‐label use of other antibiotics not stated. All patients except 1 in the intermittent group received q6h dosing. |