COL-ECMO2022

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F23%3A00131098" target="_blank" >RIV/00216224:14110/23:00131098 - isvavai.cz</a>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

čeština

Název v původním jazyce

COL-ECMO2022

Popis výsledku v původním jazyce

The COL-ECMO2022 study is a prospective, non-randomized, single-center, phase IV clinical trial designed to assess the influence of extracorporeal membrane oxygenation (ECMO) on the pharmacokinetics of colistin. Colistin is administered as colistin methanesulfonate (CMS), which is spontaneously hydrolyzed to the active form. Colistin is also a drug with a narrow therapeutic window; the limiting factors are mainly nephrotoxicity and neurotoxicity, both dependent on plasma concentrations. Thirdly, there are limited data on the influence of ECMO on colistin and CMS pharmacokinetics. Up to 30 patients treated with colistin will be included in the study and assigned to one of two arms, depending on the presence/absence of ECMO. All study participants will receive standard CMS dose intravenously. The plasma concentrations of colistin and CMS taken at defined intervals will be assessed by high-performance liquid chromatography-mass spectrometry. Patients will participate in the clinical trial for a maximum of three monitored dosing intervals. A population pharmacokinetic model will be developed to assess the influence of ECMO on pharmacokinetics. The study has been approved by the Ethics Committee of St. Anne's University Hospital Brno (Number 10ML/2022-AM). EudraCT Number of the study is 2022-000291-19, registered on June 21, 2022. The study was registered at the Clinical Trials register https://clinicaltrials.gov/ct2/show/NCT05542446 on September 15, 2022. Acknowledgment: Activities related to the development of a method for the determination of colistin in plasma were covered by a grant Verification of colistin adsorption on the ECMO circuit (DSGC-2021-0179)“ within the project OP VVV" Improvement of the Doctoral Student Grant Competition Schemes and their Pilot Implementation", reg.no. CZ.02.2.69/0.0/0.0/19_073/0016713. Some activities connected with study preparation are created in collaboration with MED MUNI through the CZECRIN project (LM2023049), supported by the national budget through MEYS and from the European Regional Development Fund – project CZECRIN_4 PATIENTS (CZ.02.1.01 / 0.0 / 0.0 / 16_013 / 0001826).

Název v anglickém jazyce

COL-ECMO2022

Popis výsledku anglicky

The COL-ECMO2022 study is a prospective, non-randomized, single-center, phase IV clinical trial designed to assess the influence of extracorporeal membrane oxygenation (ECMO) on the pharmacokinetics of colistin. Colistin is administered as colistin methanesulfonate (CMS), which is spontaneously hydrolyzed to the active form. Colistin is also a drug with a narrow therapeutic window; the limiting factors are mainly nephrotoxicity and neurotoxicity, both dependent on plasma concentrations. Thirdly, there are limited data on the influence of ECMO on colistin and CMS pharmacokinetics. Up to 30 patients treated with colistin will be included in the study and assigned to one of two arms, depending on the presence/absence of ECMO. All study participants will receive standard CMS dose intravenously. The plasma concentrations of colistin and CMS taken at defined intervals will be assessed by high-performance liquid chromatography-mass spectrometry. Patients will participate in the clinical trial for a maximum of three monitored dosing intervals. A population pharmacokinetic model will be developed to assess the influence of ECMO on pharmacokinetics. The study has been approved by the Ethics Committee of St. Anne's University Hospital Brno (Number 10ML/2022-AM). EudraCT Number of the study is 2022-000291-19, registered on June 21, 2022. The study was registered at the Clinical Trials register https://clinicaltrials.gov/ct2/show/NCT05542446 on September 15, 2022. Acknowledgment: Activities related to the development of a method for the determination of colistin in plasma were covered by a grant Verification of colistin adsorption on the ECMO circuit (DSGC-2021-0179)“ within the project OP VVV" Improvement of the Doctoral Student Grant Competition Schemes and their Pilot Implementation", reg.no. CZ.02.2.69/0.0/0.0/19_073/0016713. Some activities connected with study preparation are created in collaboration with MED MUNI through the CZECRIN project (LM2023049), supported by the national budget through MEYS and from the European Regional Development Fund – project CZECRIN_4 PATIENTS (CZ.02.1.01 / 0.0 / 0.0 / 16_013 / 0001826).

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

2023

Kód důvěrnosti údajů

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