COL-ECMO2022
The result's identifiers
Result code in 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>
Result on the web
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DOI - Digital Object Identifier
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Alternative languages
Result language
čeština
Original language name
COL-ECMO2022
Original language description
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).
Czech name
COL-ECMO2022
Czech description
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).
Classification
Type
O - Miscellaneous
CEP classification
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OECD FORD branch
30104 - Pharmacology and pharmacy
Result continuities
Project
<a href="/en/project/LM2023049" target="_blank" >LM2023049: Czech National Node of the European Clinical Research Infrastructures Network</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů