Current Research in Colistin Therapeutic Drug Monitoring – Pre-eliminary Results of Investigator-Initiated Clinical Trial COL-ECMO2022

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F24%3A00138115" target="_blank" >RIV/00216224:14110/24:00138115 - isvavai.cz</a>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Current Research in Colistin Therapeutic Drug Monitoring – Pre-eliminary Results of Investigator-Initiated Clinical Trial COL-ECMO2022

Popis výsledku v původním jazyce

Recap the shortcomings in colistin therapeutic drug monitoring (TDM) and summarize lessons learned from several follow-up projects that address these gaps. A literature review on colistin TDM. Development of a method for determining colistin/CMS in three matrices. Short-term stability tests of colistin and CMS in the above matrices. Preliminary results of a prospective, non-randomized, single-center phase IV pharmacokinetic clinical trial to assess the effect of ECMO on the pharmacokinetics of colistin and CMS (COL-ECMO2022 trial). The primary shortcomings in colistin TDM are the lack of a method for routine measurement, insufficient stability data for samples, a limited availability of the population pharmacokinetic models. A simple LC-MS/MS method for the determination of both substrates has been established and validated in the associated laboratory; it is currently the only facility in the Czech Republic capable of determining colistin and CMS in plasma/serum. The total analysis time is 5 minutes. Short-term stability data confirming a relationship between colistin/CMS stability and temperature/temperature and concentration provide valuable input for preanalytical sample processing. 23 Preliminary results of the pharmacokinetic study show a high colistin exposure despite standard dosage use. Colistin AUCSS,24h was 165±128 mg.h/L, cSS corresponds to 6.9±5.3 mg/L. Considering the variable relationship between CMS concentration and achieved colistin concentrations, the determination of colistin itself, especially trough concentration, seems to be crucial; the determination of CMS is not essential. Real-time TDM appears to be a fundamental condition for the rational use of colistin, and the above data helps with practical implementation.

Název v anglickém jazyce

Current Research in Colistin Therapeutic Drug Monitoring – Pre-eliminary Results of Investigator-Initiated Clinical Trial COL-ECMO2022

Popis výsledku anglicky

Recap the shortcomings in colistin therapeutic drug monitoring (TDM) and summarize lessons learned from several follow-up projects that address these gaps. A literature review on colistin TDM. Development of a method for determining colistin/CMS in three matrices. Short-term stability tests of colistin and CMS in the above matrices. Preliminary results of a prospective, non-randomized, single-center phase IV pharmacokinetic clinical trial to assess the effect of ECMO on the pharmacokinetics of colistin and CMS (COL-ECMO2022 trial). The primary shortcomings in colistin TDM are the lack of a method for routine measurement, insufficient stability data for samples, a limited availability of the population pharmacokinetic models. A simple LC-MS/MS method for the determination of both substrates has been established and validated in the associated laboratory; it is currently the only facility in the Czech Republic capable of determining colistin and CMS in plasma/serum. The total analysis time is 5 minutes. Short-term stability data confirming a relationship between colistin/CMS stability and temperature/temperature and concentration provide valuable input for preanalytical sample processing. 23 Preliminary results of the pharmacokinetic study show a high colistin exposure despite standard dosage use. Colistin AUCSS,24h was 165±128 mg.h/L, cSS corresponds to 6.9±5.3 mg/L. Considering the variable relationship between CMS concentration and achieved colistin concentrations, the determination of colistin itself, especially trough concentration, seems to be crucial; the determination of CMS is not essential. Real-time TDM appears to be a fundamental condition for the rational use of colistin, and the above data helps with practical implementation.

Druh

O - Ostatní výsledky

CEP obor

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OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

<a href="/cs/project/LM2023049" target="_blank" >LM2023049: Český národní uzel Evropské sítě infrastruktur klinického výzkumu</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2024

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů