Evidence map›Paper›PMID 37518089›Full record

ArticleBMJ open2023

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.

Pavel Suk, Jitka Rychlíčková, Lenka Součková, Vendula Kubíčková, Karel Urbánek

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05542446 (Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05542446 phase4terminatednot on this map

Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation

TypeinterventionalSponsorSt. Anne's University Hospital Brno, Czech RepublicRan2022 to 2024Enrolled8ConditionsColistinArmsColistin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 2 countries.

Pavel SukInternational Clinical Research Center, Saint Anne's University Hospital Brno, Brno, Czech Republic.
Jitka RychlíčkováInternational Clinical Research Center, Saint Anne's University Hospital Brno, Brno, Czech Republic rychlickova@med.muni.cz.ORCID 0000-0001-5764-5326
Lenka SoučkováDepartment of Pharmacology, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
Vendula KubíčkováDepartment of Pharmacology, Faculty of Medicine and Dentistry, Palacky University Olomouc, Olomouc, Czech Republic.
Karel UrbánekDepartment of Pharmacology, Faculty of Medicine and Dentistry, Palacky University Olomouc, Olomouc, Czech Republic.
Masaryk University · CZPalacký University Olomouc · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionColistin 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. TRIAL REGISTRATION NUMBERS: EudraCT Number 2022-000291-19; NCT05542446.

Indexed as

COVID-19Extracorporeal Membrane OxygenationAnti-Bacterial AgentsClinical Trials, Phase IV as TopicColistinCritical IllnessHumansProspective StudiesRandomized Controlled Trials as TopicAnti-Bacterial AgentsColistinAdult intensive & critical careCLINICAL PHARMACOLOGYMICROBIOLOGY

Identifiers

PMID37518089
PMCPMC10387630
OpenAlexW4385406438

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.