PMID- 23944203
OWN - NLM
STAT- MEDLINE
DCOM- 20131114
LR  - 20130815
IS  - 1441-2772 (Print)
IS  - 1441-2772 (Linking)
VI  - 15
IP  - 3
DP  - 2013 Sep
TI  - 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.
PG  - 179-85
AB  - 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 betalactam 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 ICUfree 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.
FAU - Dulhunty, Joel M
AU  - Dulhunty JM
AD  - Department of Intensive Care Medicine, Royal Brisbane and Women's Hospital, 
      Brisbane, QLD, Australia. Joel_Dulhunty@health.qld.gov.au
FAU - Roberts, Jason A
AU  - Roberts JA
FAU - Davis, Joshua S
AU  - Davis JS
FAU - Webb, Steven A R
AU  - Webb SA
FAU - Bellomo, Rinaldo
AU  - Bellomo R
FAU - Gomersall, Charles
AU  - Gomersall C
FAU - Shirwadkar, Charudatt
AU  - Shirwadkar C
FAU - Eastwood, Glenn M
AU  - Eastwood GM
FAU - Myburgh, John
AU  - Myburgh J
FAU - Paterson, David L
AU  - Paterson DL
FAU - Starr, Therese
AU  - Starr T
FAU - Udy, Andrew A
AU  - Udy AA
FAU - Paul, Sanjoy K
AU  - Paul SK
FAU - Lipman, Jeffrey
AU  - Lipman J
CN  - Australian and New Zealand Intensive Care Society Clinical Trials Group
CN  - Australasian Society for Infectious Diseases Clinical Research Network
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - Crit Care Resusc
JT  - Critical care and resuscitation : journal of the Australasian Academy of Critical 
      Care Medicine
JID - 100888170
RN  - 0 (beta-Lactams)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Critical Care/*methods
MH  - Critical Illness/*therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Sepsis/*drug therapy
MH  - Treatment Outcome
MH  - beta-Lactams/*administration & dosage
EDAT- 2013/08/16 06:00
MHDA- 2013/11/15 06:00
CRDT- 2013/08/16 06:00
PHST- 2013/08/16 06:00 [entrez]
PHST- 2013/08/16 06:00 [pubmed]
PHST- 2013/11/15 06:00 [medline]
PST - ppublish
SO  - Crit Care Resusc. 2013 Sep;15(3):179-85.