Evidence map›Paper›PMID 36471223›Full record

ArticleClinical pharmacokinetics2023

Pilot Pharmacokinetic Study in Healthy Adults Using Intravascular Microdialysis Catheters Modified for Use in Paediatric Patients to Assess Vancomycin Blood Levels.

Valentin Al Jalali, Martin Bauer, Michael Wölfl-Duchek, Maysa Sarhan, Sebastian G Wicha, Stefan Poschner, Walter Jäger, Franz König, Christoph Male, Markus Zeitlinger

Open access · hybridAbstract read
In one paragraph

Article in Clinical pharmacokinetics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 36% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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

10 authors at 4 institutions in 2 countries.

Valentin Al JalaliDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.ORCID 0000-0002-9196-1936
Martin BauerDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Michael Wölfl-DuchekDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Maysa SarhanDivision of Nephrology and Dialysis, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
Sebastian G WichaDepartment of Clinical Pharmacy, Institute of Pharmacy, University of Hamburg, Hamburg, Germany.
Stefan PoschnerDivision of Pharmaceutical Chemistry, Department of Pharmaceutical Sciences, University of Vienna, Vienna, Austria.
Walter JägerDivision of Pharmaceutical Chemistry, Department of Pharmaceutical Sciences, University of Vienna, Vienna, Austria.
Franz KönigCenter for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.
Christoph MaleDepartment of Pediatrics, Medical University of Vienna, Vienna, Austria.
Markus ZeitlingerDepartment of Clinical Pharmacology, Vienna University Hospital, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. markus.zeitlinger@meduniwien.ac.at.ORCID 0000-0001-5500-5878
Vienna General Hospital · ATMedical University of Vienna · ATUniversity of Vienna · ATUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveExhaustive pharmacokinetic (PK) studies in paediatric patients are unavailable for most antibiotics and feasibility of PK studies is limited by challenges, such as low blood volume and venipuncture-related pain. Microdialysis (MD) represents a promising method to overcome these obstacles. The aim of this proof-of-concept study was to develop and validate modified MD catheters that can be used to obtain concentration-time profiles of antibiotics in paediatric patients.

methodsFollowing extensive in vitro MD experiments, a prospective open-labelled study in ten healthy adult volunteers (HVs) was conducted. Subjects received a single intravenous dose of 1000 mg vancomycin, then plasma and intravascular microdialysate were sampled over 24 h. In vivo MD probe calibration was conducted using the retrodialysis technique. Plasma protein binding was measured using ultrafiltration. Confirmation of the measurements was performed using a Bland-Altman plot, relevant PK parameters were calculated, and a pharmacometric model was established.

resultsNo safety issues were encountered. The concentration-time curves of microdialysate and plasma measurements showed good alignment. The Bland-Altman plot yielded a mean bias of 0.19 mg/L and 95% limits of agreement of - 9.34 to 9.71 mg/L. A two-compartment model best described plasma PK, model-based estimates for recovery of the MD probes being in high agreement with the observed values. Quantified estimates of fraction unbound were comparable between plasma and microdialysate (p = 0.56).

conclusionsAn innovative MD catheter that can be inserted into small intravenous lines was successfully developed and applied in HV. This proof-of-concept study is encouraging and opens the way to further experiments leading towards future use of MD in paediatric patients.

Indexed as

Anti-Bacterial AgentsVancomycinAdultCathetersChildHumansMicrodialysisProspective StudiesAnti-Bacterial AgentsVancomycin

Identifiers

PMID36471223
PMCPMC9898326
OpenAlexW4310776650

What OpenQuestion holds

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Registered trials

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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.