Changes of colistin pharmacokinetics in critically ill patients
due to the extracorporeal membrane oxygenation: protocol for
the COL-ECMO2022 trial - a prospective, non-randomised,
open-label phase IV pharmacokinetic clinical trial

J 2023

Changes of colistin pharmacokinetics in critically ill patients due to the extracorporeal membrane oxygenation: protocol for the COL-ECMO2022 trial - a prospective, non-randomised, open-label phase IV pharmacokinetic clinical trial

SUK, Pavel, Jitka RYCHLÍČKOVÁ, Lenka SOUČKOVÁ, Vendula KUBICKOVA, Karel URBANEK et. al.

Basic information

Original name

Changes of colistin pharmacokinetics in critically ill patients due to the extracorporeal membrane oxygenation: protocol for the COL-ECMO2022 trial - a prospective, non-randomised, open-label phase IV pharmacokinetic clinical trial

Authors

SUK, Pavel (203 Czech Republic, guarantor, belonging to the institution), Jitka RYCHLÍČKOVÁ (203 Czech Republic, belonging to the institution), Lenka SOUČKOVÁ (203 Czech Republic, belonging to the institution), Vendula KUBICKOVA (203 Czech Republic) and Karel URBANEK (203 Czech Republic)

Edition

BMJ Open, London, BMJ Publishing Group, 2023, 2044-6055

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30230 Other clinical medicine subjects

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 2.900 in 2022

RIV identification code

RIV/00216224:14110/23:00131956

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1136/bmjopen-2023-071649

UT WoS

001042144300030

Keywords (in Czech)

Adult intensive & critical care; CLINICAL PHARMACOLOGY; MICROBIOLOGY

Keywords in English

Adult intensive & critical care; CLINICAL PHARMACOLOGY; MICROBIOLOGY

Abstract

V originále

Introduction Colistin is a lipopeptide antibiotic administered as an inactive prodrug-colistin methanesulfonate (CMS). Colistin is a drug with a narrow therapeutic window; the limiting factors are mainly nephrotoxicity and neurotoxicity, dependent on plasma concentrations. The number of patients with infections caused by multidrug-resistant Gram-negative bacteria sensitive only to colistin and the number of patients requiring extracorporeal membrane oxygenation (ECMO) support for severe respiratory failure increased significantly in association with COVID-19-induced infections. ECMO can generally affect the pharmacokinetics of drugs by creating a new compartment.Methods and analysis The COL-ECMO2022 study is a prospective, non-randomised, single-centre, phase IV pharmacokinetic clinical trial designed to assess the influence of ECMO on the pharmacokinetics of colistin and CMS. 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. A difference greater than 25% is considered clinically significant.Ethics and dissemination The study has been approved by the Ethics Committee of St. Anne's University Hospital Brno (Number 10ML/2022-AM). Related manuscripts will be submitted to peer-review journals.

Links

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(CEP code: EF16_013/0001826)

Name: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií

Investor: Ministry of Education, Youth and Sports of the CR, Priority axis 1: Strengthening capacities for high-quality research

LM2023049, research and development project

Name: Český národní uzel Evropské sítě infrastruktur klinického výzkumu

Investor: Ministry of Education, Youth and Sports of the CR

Citovat

SUK, Pavel, Jitka RYCHLÍČKOVÁ, Lenka SOUČKOVÁ, Vendula KUBICKOVA and Karel URBANEK. Changes of colistin pharmacokinetics in critically ill patients due to the extracorporeal membrane oxygenation: protocol for the COL-ECMO2022 trial - a prospective, non-randomised, open-label phase IV pharmacokinetic clinical trial. BMJ Open. London: BMJ Publishing Group, 2023, vol. 13, No 7, p. 1-8. ISSN 2044-6055. Available from: https://dx.doi.org/10.1136/bmjopen-2023-071649.

@article{2327157,
   author = {Suk, Pavel and Rychlíčková, Jitka and Součková, Lenka and Kubickova, Vendula and Urbanek, Karel},
   article_location = {London},
   article_number = {7},
   doi = {http://dx.doi.org/10.1136/bmjopen-2023-071649},
   keywords = {Adult intensive & critical care; CLINICAL PHARMACOLOGY; MICROBIOLOGY},
   language = {eng},
   issn = {2044-6055},
   journal = {BMJ Open},
   title = {Changes of colistin pharmacokinetics in critically ill patients due to the extracorporeal membrane oxygenation: protocol for the COL-ECMO2022 trial - a prospective, non-randomised, open-label phase IV pharmacokinetic clinical trial},
   url = {https://bmjopen.bmj.com/content/bmjopen/13/7/e071649.full.pdf},
   volume = {13},
   year = {2023}
}

TY  - JOUR
ID  - 2327157
AU  - Suk, Pavel - Rychlíčková, Jitka - Součková, Lenka - Kubickova, Vendula - Urbanek, Karel
PY  - 2023
TI  - Changes of colistin pharmacokinetics in critically ill patients due to the extracorporeal membrane oxygenation: protocol for the COL-ECMO2022 trial - a prospective, non-randomised, open-label phase IV pharmacokinetic clinical trial
JF  - BMJ Open
VL  - 13
IS  - 7
SP  - 1-8
EP  - 1-8
PB  - BMJ Publishing Group
SN  - 20446055
KW  - Adult intensive &
KW  - critical care
KW  - CLINICAL PHARMACOLOGY
KW  - MICROBIOLOGY
UR  - https://bmjopen.bmj.com/content/bmjopen/13/7/e071649.full.pdf
N2  - Introduction Colistin is a lipopeptide antibiotic administered as an inactive prodrug-colistin methanesulfonate (CMS). Colistin is a drug with a narrow therapeutic window; the limiting factors are mainly nephrotoxicity and neurotoxicity, dependent on plasma concentrations. The number of patients with infections caused by multidrug-resistant Gram-negative bacteria sensitive only to colistin and the number of patients requiring extracorporeal membrane oxygenation (ECMO) support for severe respiratory failure increased significantly in association with COVID-19-induced infections. ECMO can generally affect the pharmacokinetics of drugs by creating a new compartment.Methods and analysis The COL-ECMO2022 study is a prospective, non-randomised, single-centre, phase IV pharmacokinetic clinical trial designed to assess the influence of ECMO on the pharmacokinetics of colistin and CMS. 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. A difference greater than 25% is considered clinically significant.Ethics and dissemination The study has been approved by the Ethics Committee of St. Anne's University Hospital Brno (Number 10ML/2022-AM). Related manuscripts will be submitted to peer-review journals.
ER  -

SUK, Pavel, Jitka RYCHLÍČKOVÁ, Lenka SOUČKOVÁ, Vendula KUBICKOVA and Karel URBANEK. Changes of colistin pharmacokinetics in critically ill patients due to the extracorporeal membrane oxygenation: protocol for the COL-ECMO2022 trial - a prospective, non-randomised, open-label phase IV pharmacokinetic clinical trial. \textit{BMJ Open}. London: BMJ Publishing Group, 2023, vol.~13, No~7, p.~1-8. ISSN~2044-6055. Available from: https://dx.doi.org/10.1136/bmjopen-2023-071649.

Detailed Information on Publication Record