Evidence map›Paper›PMID 38166710›Full record

ArticleBMC neurology2024

Enhanced renal clearance impacts levetiracetam concentrations in patients with traumatic brain injury with and without augmented renal clearance.

Aaron M Cook, Kaylee Hall, Jimmi Hatton Kolpek, Kathryn A Morbitzer, J Dedrick Jordan, Denise H Rhoney

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02437838 (Optimizing Drug Doses to Improve Outcomes of Critically Ill Patients), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT02437838 completednot on this map

Optimizing Drug Doses to Improve Outcomes of Critically Ill Patients

TypeobservationalSponsorUniversity of North Carolina, Chapel HillRan2015 to 2016Enrolled20ConditionsTraumatic Brain Injury, Kidney FunctionalArmsNo Intervention
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Observational
  5. Review
  6. 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

6 authors at 3 institutions in 1 country.

Aaron M CookDepartment of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, KY, USA.
Kaylee HallDepartment of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, KY, USA.
Jimmi Hatton KolpekDepartment of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, KY, USA.
Kathryn A MorbitzerDivision of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Campus Box 7574, Chapel Hill, NC, 27599, USA.
J Dedrick JordanDepartments of Neurology and Neurosurgery, Duke University, Durham, NC, USA.
Denise H RhoneyDivision of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Campus Box 7574, Chapel Hill, NC, 27599, USA. drhoney@unc.edu.
University of Kentucky · USDuke University · USUniversity of North Carolina at Chapel Hill · US

Funding

Mulit-instiutitional CTSA Award and National Center for Research Resources and Nations Center for Advancing Translational Sciences, National Institutes of Health MCTSA005
6 · The paper itself

Abstract

backgroundThe purpose of this study was to examine the impact of ARC on levetiracetam concentrations during the first week following acute TBI. The hypothesis was levetiracetam concentrations are significantly lower in TBI patients with augmented renal clearance (ARC) compared to those with normal renal clearance.

methodsThis is a prospective cohort pharmacokinetic study of adults with moderate to severe TBI treated with levetiracetam during the first week after injury. Serial blood collections were performed daily for analysis of levetiracetam, cystatin C, and 12-hr creatinine clearance (CrCl) determinations. Patients were divided into two cohorts: with (CrCl ≥130 ml/min/1.73 m

resultsTwenty-two patients with moderate to severe TBI were included. The population consisted primarily of young male patients with severe TBI (mean age 40 years old, 68% male, median admission GCS 4). Each received levetiracetam 1000 mg IV every 12 h for the study period. ARC was present in 77.3% of patients, with significantly lower levetiracetam concentrations in ARC patients and below the conservative therapeutic range (< 6mcg/mL) for all study days. In patients without ARC, the serum concentrations were also below the expected range on all but two study days (Days 4 and 5). Four of the 22 (18.2%) patients exhibited seizure activity during the study period (two of these patients exhibited ARC). Cystatin C concentrations were significantly lower in patients with ARC, though the mean for all patients was within the typical normal range.

conclusionsARC has a high prevalence in patients with moderate to severe TBI. Levetiracetam concentrations after standard dosing were low in all TBI patients, but significantly lower in patients with ARC. This study highlights the need to consider personalized drug dosing in TBI patients irrespective of the presence of ARC. CLINICAL

trial registrationThis study was registered at cliicaltrials.gov (NCT02437838) Registered on 08/05/2015, https://clinicaltrials.gov/ct2/show/NCT02437838 .

Indexed as

Brain Injuries, TraumaticCystatin CAdultFemaleHumansLevetiracetamMaleProspective StudiesCystatin CLevetiracetamAugmented renal clearanceCreatinine clearanceLevetiracetamPharmacokineticsSeizure prophylaxisTraumatic brain injury

Identifiers

PMID38166710
PMCPMC10759330
OpenAlexW4390497059

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.