SaMpling Antibiotics in Renal Replacement Therapy (SMARRT): an observational pharmacokinetic study in critically ill patients

BMC Infectious Diseases

Study Protocol

Rinaldo Bellomo¹  Darren M. Roberts²  Renae Deans²  Steven C. Wallis²  Jeffrey Lipman³  Jason A. Roberts³  Sanjoy K. Paul⁴  Louise Cole⁵  Gavin M. Joynt⁶  Gordon Y. S. Choi⁶  Therese Starr⁷  Melissa Lassig-Smith⁷  Dianne Stephens⁸  John Turnidge⁹  Sandra Peake^1,10  Michael S. Roberts^1,11 

[1] Austin Hospital, Victoria, Australia;Burns Trauma and Critical Care Research Centre, The University of Queensland, Level 3 Ned Hanlon Building, Royal Brisbane and Women’s Hospital, Herston, 4029, Queensland, Australia;Burns Trauma and Critical Care Research Centre, The University of Queensland, Level 3 Ned Hanlon Building, Royal Brisbane and Women’s Hospital, Herston, 4029, Queensland, Australia;Royal Brisbane & Women’s Hospital, Queensland, Australia;Clinical Trials & Biostatistics Unit, QIMR Berghofer, Queensland, Australia;Nepean Hospital, New South Wales, Australia;Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region, China;Royal Brisbane & Women’s Hospital, Queensland, Australia;Royal Darwin Hospital, Northern Territory, Australia;Royal Women’s and Children’s Hospital, Queensland, Australia;The Queen Elizabeth Hospital, South Australia, Australia;Therapeutics Research Unit, The University of Queensland, Queensland, Australia;

关键词: Sepsis;    Antibiotic dosing;    Dialysis;    Pharmacokinetics;    Pharmacodynamics;    Vancomycin;    Piperacillin;    Tazobactam;    Meropenem;    Linezolid;   

DOI  :  10.1186/s12879-016-1421-6

 received in 2015-10-14, accepted in 2016-02-09,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundOptimal antibiotic dosing is key to maximising patient survival, and minimising the emergence of bacterial resistance. Evidence-based antibiotic dosing guidelines for critically ill patients receiving RRT are currently not available, as RRT techniques and settings vary greatly between ICUs and even individual patients. We aim to develop a robust, evidence-based antibiotic dosing guideline for critically ill patients receiving various forms of RRT. We further aim to observe whether therapeutic antibiotic concentrations are associated with reduced 28-day mortality.Methods/DesignWe designed a multi-national, observational pharmacokinetic study in critically ill patients requiring RRT. The study antibiotics will be vancomycin, linezolid, piperacillin/tazobactam and meropenem. Pharmacokinetic sampling of each patient’s blood, RRT effluent and urine will take place during two separate dosing intervals. In addition, a comprehensive data set, which includes the patients’ demographic and clinical parameters, as well as modality, technique and settings of RRT, will be collected. Pharmacokinetic data will be analysed using a population pharmacokinetic approach to identify covariates associated with changes in pharmacokinetic parameters in critically ill patients with AKI who are undergoing RRT for the five commonly prescribed antibiotics.DiscussionUsing the comprehensive data set collected, the pharmacokinetic profile of the five antibiotics will be constructed, including identification of RRT and other factors indicative of the need for altered antibiotic dosing requirements. This will enable us to develop a dosing guideline for each individual antibiotic that is likely to be relevant to any critically ill patient with acute kidney injury receiving any of the included forms of RRT.Trial registrationAustralian New Zealand Clinical Trial Registry (ACTRN12613000241730) registered 28 February 2013

【 授权许可】

CC BY   
© Roberts et al. 2016