Pilot randomised controlled trial of continuous beta-lactam infusion compared with intermittent dosing in critically ill patients
In critically ill patients with severe sepsis how does continuous beta-lactam infusion compared with intermittent beta-lactam dosing effect pharmacodynamics and clinical response to treatment? A pilot randomised controlled trial.
Beta-Lactam Infusion Group
60 participants
Apr 14, 2010
Interventional
Conditions
Summary
The purpose of this pilot randomised controlled trial is to establish the fundamental elements (feasibility, adequacy of blinding, pharmacodynamic effect and separation of endpoints) required to proceed with a large multi-centre randomised controlled trial of beta-lactam antibiotics delivered by continuous infusion compared to standard bolus dosing in critically ill patients. We hypothesise that continuous infusion will more consistently achieve pharmacodynamic endpoints than standard bolus dosing, resulting in improved clinical outcomes.
Eligibility
Inclusion Criteria3
- Confirmed or suspected infection with new organ dysfunction
- Commencement within the previous 24 hours or planned commencement of ticarcillin/clavulanate, piperacillin/tazobactam or meropenem
- Expected or actual ICU stay greater than 48 hours
Exclusion Criteria6
- Allergy or potential allergy to study medications
- Receiving palliative or supportive treatment only at the time of screening
- Receiving contrinuous renal replacement therapy
- No central venous catheter access with 3 or more lumens
- Receipt of the study drug of interest for > 24 hours prior to enrolment
- Discharge from the ICU within 48 hours
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Interventions
Continuous infusion over 24 hours of one of the following beta-lactam antibiotics: ticarcillin/clavulanate, piperacillin/tazobactam or meropenem; antibiotic choice, dose and duration of treatment are clinician chosen
Locations(1)
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ACTRN12610000238077