Roberts 2009b.
Methods | Prospective, open‐label, randomised trial. | |
Participants | 10 critically ill patients (mean age range 55 to 57 years; 70% male) with a clinical indication for meropenem, normal renal function, and known or suspected sepsis. Exclusion: not stated. |
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Interventions | Meropenem 500 mg i.v. infused over 3 min, followed by 3000 mg continuous infusion over 24 h (given as three 1000‐mg infusions over 8 h) vs meropenem 1500 mg i.v. infused over 5 min, followed by 1000 mg infused over 3 min q8h. | |
Outcomes | Subcutaneous tissue concentration‐time profiles. Plasma concentration‐time profiles. Pharmacokinetic variability. Plasma pharmacokinetic‐pharmacodynamic profile. Expected probability of target attainment. |
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Notes | No clinical outcomes specified. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomised using random numbers concealed in opaque sealed envelopes" (pg. 143); however, no sequence generation mentioned. |
Allocation concealment (selection bias) | Low risk | "Patients were randomised using random numbers concealed in opaque sealed envelopes" (pg. 143). |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blind. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated whether any patients were lost to follow‐up or withdrew from the study. |
Selective reporting (reporting bias) | Unclear risk | No protocol cited. |
Other bias | Unclear risk | Open‐label use of other antibiotics not stated. |