A protocol for a multicentre randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients with severe sepsis: The BLING II study

J.M. Dulhunty, J.A. Roberts, J.S. Davis, Steve Webb, R.K. Bellomo, C.D. Gomersall, C.G. Shirwadkar, G.M. Eastwood, J.A. Myburgh, D.L. Paterson, T. Starr, A.A. Udy, S.K. Paul, J. Lipman

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    Abstract

    Background and rationale: Beta-lactam antibiotics are largely administered by bolus dosing, despite displaying time-dependent pharmacokinetics and pharmacodynamics and there being a strong rationale for continuous administration. The randomised controlled trials conducted to date comparing the mode of beta-lactam administration have been inconclusive and limited by non-equivalent dosing, unblinded administration and small sample sizes.
    Objective: A multicentre, randomised controlled trial (the Beta-lactam Infusion Group [BLING] II study) is currently under way, comparing continuous infusion to standard bolus administration of beta-lactam antibiotics in critically ill patients, independent of dose.
    Design, settings, participants and interventions: BLING II is a Phase IIB, double-blinded, randomised controlled trial recruiting 420 intensive care unit patients with severe sepsis to receive one of three beta-lactam study antibiotics (ticarcillin-clavulanate, piperacillin-tazobactam or meropenem) by either continuous infusion or intermittent bolus administration. Main outcome measures: The primary outcome is ICU-free days at Day 28. Secondary outcomes include 90-day survival, clinical cure 14 days after study antibiotic cessation, organ failure-free days at Day 14 and duration of bacteraemia.
    Results and conclusions: The study started in July 2012 and will provide clinical evidence as to whether continuous infusion of beta-lactam antibiotics is superior to intermittent bolus administration in critically ill patients with severe sepsis. A Phase III study powered for a survival end point may be justified, based on the results of our study.
    Original languageEnglish
    Pages (from-to)179-185
    JournalCritical Care and Resuscitation
    Volume15
    Issue number3
    Publication statusPublished - Sep 2013

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    Dulhunty, J. M., Roberts, J. A., Davis, J. S., Webb, S., Bellomo, R. K., Gomersall, C. D., Shirwadkar, C. G., Eastwood, G. M., Myburgh, J. A., Paterson, D. L., Starr, T., Udy, A. A., Paul, S. K., & Lipman, J. (2013). A protocol for a multicentre randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients with severe sepsis: The BLING II study. Critical Care and Resuscitation, 15(3), 179-185. http://www.cicm.org.au/journal_load.php?year=2013&month=september&page=179.php&title=