Evidence map›Paper›PMID 34297338›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2021

Quantification and Explanation of the Variability of First-Dose Amikacin Concentrations in Critically Ill Patients Admitted to the Emergency Department: A Population Pharmacokinetic Analysis.

Sabrina De Winter, Reinier van Hest, Erwin Dreesen, Pieter Annaert, Joost Wauters, Wouter Meersseman, Nele Van den Eede, Stefanie Desmet, Sandra Verelst, Peter Vanbrabant and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02365272 (Pharmacokinetic/Pharmacodynamic), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT02365272 phase4completednot on this map

Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation of Amikacin in Patients With Severe Sepsis or Septic Shock Admitted at the Emergency Department(ED)

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2012 to 2014Enrolled100ConditionsSepsisArmsAmikacin
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. 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

12 authors.

Sabrina De Winter *Department of Pharmacy, Univesity Hospitals Leuven, Leuven, Belgium. sabrina.dewinter@uzleuven.be.ORCID http://orcid.org/0000-0002-5253-2960
Reinier van Hest *Department of Hospital Pharmacy and Clinical Pharmacology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Erwin DreesenDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-0785-2930
Pieter AnnaertDepartment of Pharmaceutical and Pharmacological Sciences, Drug Delivery and Disposition, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0003-3525-7351
Joost WautersDepartment of Internal Medicine, University Hospitals Leuven, Leuven, Belgium.
Wouter MeerssemanDepartment of Internal Medicine, University Hospitals Leuven, Leuven, Belgium.
Nele Van den EedeLaboratory of Clinical Bacteriology and Mycology, University Hospitals Leuven, Leuven, Belgium.
Stefanie DesmetLaboratory of Clinical Bacteriology and Mycology, University Hospitals Leuven, Leuven, Belgium.
Sandra VerelstDepartment of Emergency Medicine, University Hospitals Leuven, Leuven, Belgium.
Peter VanbrabantDepartment of Internal Medicine, University Hospitals Leuven, Leuven, Belgium.
Willy PeetermansDepartment of Internal Medicine, University Hospitals Leuven, Leuven, Belgium.
Isabel SprietDepartment of Pharmacy, Univesity Hospitals Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0001-6342-0676

Funding

Fonds Wetenschappelijk Onderzoek 12X9420N
6 · The paper itself

Abstract

backgroundThere may be a difference between the determinants of amikacin exposure in emergency department (ED) versus intensive care (ICU) patients, and the peak amikacin concentration varies widely between patients. Moreover, when the first dose of antimicrobials is administered to septic patients admitted to the ED, fluid resuscitation and vasopressors have just been initiated. Nevertheless, population pharmacokinetic modelling data for amikacin in ED patients are unavailable.

objectiveThe aim of this study was to quantify the interindividual variability (IIV) in the pharmacokinetics of amikacin in patients admitted to the ED and to identify the patient characteristics that explain this IIV.

methodsPatients presenting at the ED with severe sepsis or septic shock were randomly assigned to receive amikacin 25 mg/kg or 15 mg/kg intravenously. Blood samples were collected at 1, 6 and 24 h after the onset of the first amikacin infusion. Data were analysed using nonlinear mixed-effects modelling.

resultsA two-compartment population pharmacokinetic model was developed based on 279 amikacin concentrations from 97 patients. The IIV in clearance (CL) and central distribution volume (V

conclusionThe IIV of amikacin pharmacokinetics in ED patients is large. Higher doses may be considered in patients with low serum sodium levels, low total protein levels, or a high fluid balance.

trial registrationClinicalTrials.gov ID: NCT02365272.

Indexed as

AgedAged, 80 and overAmikacinAnti-Bacterial AgentsCritical IllnessDose-Response Relationship, DrugEmergency Service, HospitalFemaleHumansInfusions, IntravenousMaleMiddle AgedModels, BiologicalProspective StudiesSepsisShock, SepticAmikacinAnti-Bacterial Agents

Identifiers

PMID34297338

What OpenQuestion holds

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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.