Evidence map›Paper›PMID 31952493›Full record

ArticleBMC infectious diseases2020

The effect of therapeutic drug monitoring of beta-lactam and fluoroquinolones on clinical outcome in critically ill patients: the DOLPHIN trial protocol of a multi-centre randomised controlled trial.

A Abdulla, T M J Ewoldt, N G M Hunfeld, A E Muller, W J R Rietdijk, S Polinder, T van Gelder, H Endeman, B C P Koch

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
10.7field-weighted citation impact, top 1% 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

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 88 citations in OpenAlex.

  1. Pooled it
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  14. Target-controlled dialysis for antibiotics (TCD-ABx).Intensive care medicine experimental · 2024
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  15. Article
  16. Phenanthrenes fromJournal of natural products · 2024
    Article
  17. Article
  18. Article
  19. The OPAT opportunity for beta-lactam individualization.Antimicrobial stewardship & healthcare epidemiology : ASHE · 2024
    Article
  20. Antibiotics (Basel, Switzerland) · 2023
    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

9 authors at 1 institution in 1 country.

A AbdullaDepartment of Hospital Pharmacy, Erasmus University Medical Center, P.O. Box 2040, 3000, CA, Rotterdam, the Netherlands. a.abdulla@erasmusmc.nl.ORCID http://orcid.org/0000-0002-2158-6376
T M J EwoldtDepartment of Intensive Care, Erasmus University Medical Center, Rotterdam, The Netherlands.
N G M HunfeldDepartment of Hospital Pharmacy, Erasmus University Medical Center, P.O. Box 2040, 3000, CA, Rotterdam, the Netherlands.
A E MullerDepartment of Medical Microbiology and Infectious Diseases, Erasmus University Medical Center, Rotterdam, The Netherlands.
W J R RietdijkDepartment of Intensive Care, Erasmus University Medical Center, Rotterdam, The Netherlands.
S PolinderDepartment of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands.
T van GelderDepartment of Hospital Pharmacy, Erasmus University Medical Center, P.O. Box 2040, 3000, CA, Rotterdam, the Netherlands.
H EndemanDepartment of Intensive Care, Erasmus University Medical Center, Rotterdam, The Netherlands.
B C P KochDepartment of Hospital Pharmacy, Erasmus University Medical Center, P.O. Box 2040, 3000, CA, Rotterdam, the Netherlands.
Erasmus MC · NL

Funding

ZonMw 848017008
6 · The paper itself

Abstract

backgroundCritically ill patients undergo extensive physiological alterations that will have impact on antibiotic pharmacokinetics. Up to 60% of intensive care unit (ICU) patients meet the pharmacodynamic targets of beta-lactam antibiotics, with only 30% in fluoroquinolones. Not reaching these targets might increase the chance of therapeutic failure, resulting in increased mortality and morbidity, and antibiotic resistance. The DOLPHIN trial was designed to demonstrate the added value of therapeutic drug monitoring (TDM) of beta-lactam and fluoroquinolones in critically ill patients in the ICU.

methodsA multi-centre, randomised controlled trial (RCT) was designed to assess the efficacy and cost-effectiveness of model-based TDM of beta-lactam and fluoroquinolones. Four hundred fifty patients will be included within 24 months after start of inclusion. Eligible patients will be randomly allocated to either study group: the intervention group (active TDM) or the control group (non-TDM). In the intervention group dose adjustment of the study antibiotics (cefotaxime, ceftazidime, ceftriaxone, cefuroxime, amoxicillin, amoxicillin with clavulanic acid, flucloxacillin, piperacillin with tazobactam, meropenem, and ciprofloxacin) on day 1, 3, and 5 is performed based upon TDM with a Bayesian model. The primary outcome will be ICU length of stay. Other outcomes amongst all survival, disease severity, safety, quality of life after ICU discharge, and cost effectiveness will be included. DISCUSSION: No trial has investigated the effect of early TDM of beta-lactam and fluoroquinolones on clinical outcome in critically ill patients. The findings from the DOLPHIN trial will possibly lead to new insights in clinical management of critically ill patients receiving antibiotics. In short, to TDM or not to TDM?

trial registrationEudraCT number: 2017-004677-14. Sponsor protocol name: DOLPHIN. Registered 6 March 2018 . Protocol Version 6, Protocol date: 27 November 2019.

Indexed as

Drug MonitoringAdultAnti-Bacterial AgentsBayes Theorembeta-LactamsCritical IllnessFluoroquinolonesHumansIntensive Care UnitsLength of StayMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicAnti-Bacterial Agentsbeta-LactamsFluoroquinolonesAntibioticBeta-lactamCritically ill patientsFluoroquinolonesLength of stayPharmacodynamicsPharmacokineticsRandomised controlled trialTherapeutic drug monitoring

Identifiers

PMID31952493
PMCPMC6969462
OpenAlexW3001281146

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.