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Model-informed precision dosing of beta-lactam antibiotics and ciprofloxacin in critically ill patients: a multicentre randomised clinical trial.
| Content Provider | Europe PMC |
|---|---|
| Author | Ewoldt, Tim M. J. Abdulla, Alan Rietdijk, Wim J. R. Muller, Anouk E. de Winter, Brenda C. M. Hunfeld, Nicole G. M. Purmer, Ilse M. van Vliet, Peter Wils, Evert-Jan Haringman, Jasper Draisma, Annelies Rijpstra, Tom A. Karakus, Attila Gommers, Diederik Endeman, Henrik Koch, Birgit C. P. |
| Abstract | PurposeIndividualising drug dosing using model-informed precision dosing (MIPD) of beta-lactam antibiotics and ciprofloxacin has been proposed as an alternative to standard dosing to optimise antibiotic efficacy in critically ill patients. However, randomised clinical trials (RCT) on clinical outcomes have been lacking.MethodsThis multicentre RCT, including patients admitted to the intensive care unit (ICU) who were treated with antibiotics, was conducted in eight hospitals in the Netherlands. Patients were randomised to MIPD with dose and interval adjustments based on monitoring serum drug levels (therapeutic drug monitoring) combined with pharmacometric modelling of beta-lactam antibiotics and ciprofloxacin. The primary outcome was ICU length of stay (LOS). Secondary outcomes were ICU mortality, hospital mortality, 28-day mortality, 6-month mortality, delta sequential organ failure assessment (SOFA) score, adverse events and target attainment.ResultsIn total, 388 (MIPD n = 189; standard dosing n = 199) patients were analysed (median age 64 [IQR 55–71]). We found no significant differences in ICU LOS between MIPD compared to standard dosing (10 MIPD vs 8 standard dosing; IRR = 1.16; 95% CI 0.96–1.41; p = 0.13). There was no significant difference in target attainment before intervention at day 1 (T1) (55.6% MIPD vs 60.9% standard dosing; p = 0.24) or at day 3 (T3) (59.5% vs 60.4%; p = 0.84). There were no significant differences in other secondary outcomes.ConclusionsWe could not show a beneficial effect of MIPD of beta-lactam antibiotics and ciprofloxacin on ICU LOS in critically ill patients. Our data highlight the need to identify other approaches to dose optimisation.Supplementary InformationThe online version contains supplementary material available at 10.1007/s00134-022-06921-9. |
| ISSN | 03424642 |
| Journal | Intensive Care Medicine |
| Volume Number | 48 |
| PubMed Central reference number | PMC9645317 |
| Issue Number | 12 |
| PubMed reference number | 36350354 |
| e-ISSN | 14321238 |
| DOI | 10.1007/s00134-022-06921-9 |
| Language | English |
| Publisher | Springer Berlin Heidelberg |
| Publisher Date | 2022-11-09 |
| Publisher Place | Berlin/Heidelberg |
| Access Restriction | Open |
| Rights License | Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/. © The Author(s) 2022 |
| Subject Keyword | Precision dosing Beta-lactam antibiotics Ciprofloxacin Model-informed Critically ill |
| Content Type | Text |
| Resource Type | Article |
| Subject | Critical Care and Intensive Care Medicine |
