Evidence map›Paper›PMID 32420641›Full record

Trial reportEpilepsia2020

The association of patient weight and dose of fosphenytoin, levetiracetam, and valproic acid with treatment success in status epilepticus.

Abhishek G Sathe, Jordan J Elm, James C Cloyd, James M Chamberlain, Robert Silbergleit, Jaideep Kapur, Hannah R Cock, Nathan B Fountain, Shlomo Shinnar, Daniel H Lowenstein and 3 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Epilepsia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

13 authors at 11 institutions in 2 countries.

Abhishek G SatheDepartment of Experimental and Clinical Pharmacology and Center for Orphan Drug Research, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota.ORCID 0000-0002-7348-4208
Jordan J ElmDepartment of Public Health Science, Medical University of South Carolina, Charleston, South Carolina.
James C CloydDepartment of Experimental and Clinical Pharmacology and Center for Orphan Drug Research, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota.ORCID 0000-0002-3607-6619
James M ChamberlainDivision of Emergency Medicine, Department of Pediatrics and Emergency Medicine, School of Medicine and Health Sciences, Children's National Hospital, George Washington University, Washington, District of Columbia.
Robert SilbergleitDepartment of Emergency Medicine, University of Michigan, Ann Arbor, Michigan.ORCID 0000-0003-4101-2430
Jaideep KapurDepartment of Neurology, Brain Institute, University of Virginia, Charlottesville, Virginia.ORCID 0000-0002-8608-1352
Hannah R CockClinical Neurosciences Academic Group, Institute of Molecular and Clinical Sciences, St George's University of London, London, UK.ORCID 0000-0002-5656-0141
Nathan B FountainDepartment of Neurology, Comprehensive Epilepsy Program, University of Virginia, Charlottesville, Virginia.ORCID 0000-0003-2058-0308
Shlomo ShinnarMontefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.ORCID 0000-0001-6714-3960
Daniel H LowensteinDepartment of Neurology, University of California, San Francisco, San Francisco, California.ORCID 0000-0002-5869-4020
Robin A ConwitNational Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.
Thomas P BleckFeinberg School of Medicine, Northwestern University, Chicago, Illinois.ORCID 0000-0002-8267-9787
Lisa D ColesDepartment of Experimental and Clinical Pharmacology and Center for Orphan Drug Research, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota.ORCID 0000-0003-3613-9904
University of Minnesota · USAlbert Einstein College of Medicine · USAllen Institute for Brain Science · USGeorge Washington University Hospital · USMedical University of South Carolina · USNational Institutes of Health · USNorthwestern University · USSt George's, University of London · GBUniversity of California, San Francisco · USUniversity of Michigan · USUniversity of Virginia · US

Funding

Neurologic Emergencies Treatment Trials Network: Clinical Coordinating CenterU01NS056975 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BARSAN, WILLIAM G · 2006 to 2015
$40.4M
Established Status Epilepticus Treatment Trial (ESETT)U01NS088034 · NINDS · UNIVERSITY OF VIRGINIA · PI CHAMBERLAIN, JAMES, KAPUR, JAIDEEP · 2014 to 2018
$16.3M
Neurological Emergencies Treatment Trials Network Statistical and Data ManagementU01NS059041 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DURKALSKI, VALERIE L, PALESCH, YUKO Y · 2006 to 2015
$9.1M
Established Status Epilepticus Treatment Trial (ESETT) - SDMCU01NS088023 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI ELM, JORDAN J. · 2014 to 2018
$2.0M
ESETT Pharmacokinetic-Pharmacodynamic StudyR01NS099653 · NINDS · UNIVERSITY OF MINNESOTA · PI CLOYD, JAMES C., COLES, LISA D · 2017 to 2019
$1.0M
College of Pharmacy, University of MinnesotaNINDS NIH HHS R01 NS099653NINDS NIH HHS U01 NS056975NINDS NIH HHS U01 NS059041NINDS NIH HHS U01 NS088023NINDS NIH HHS U01 NS088034
6 · The paper itself

Abstract

The Established Status Epilepticus Treatment Trial was a blinded, comparative-effectiveness study of fosphenytoin, levetiracetam, and valproic acid in benzodiazepine-refractory status epilepticus. The primary outcome was clinical seizure cessation and increased responsiveness without additional anticonvulsant medications. Weight-based dosing was capped at 75 kg. Hence, patients weighing >75 kg received a lower mg/kg dose. Logistic regression models were developed in 235 adults to determine the association of weight (≤ or >75 kg, ≤ or >90 kg), sex, treatment, and weight-normalized dose with the primary outcome and solely seizure cessation. The primary outcome was achieved in 45.1% and 42.5% of those ≤75 kg and >75 kg, respectively. Using univariate analyses, the likelihood of success for those >75 kg (odds ratio [OR] = 0.9, 95% confidence interval [CI] = 0.54-1.51) or >90 kg (OR = 0.85, 95% CI = 0.42-1.66) was not statistically different compared with those ≤75 kg or ≤90 kg, respectively. Similarly, other predictors were not significantly associated with primary outcome or clinical seizure cessation. Our findings suggest that doses, capped at 75 kg, likely resulted in concentrations greater than those needed for outcome. Studies that include drug concentrations and heavier individuals are needed to confirm these findings.

Indexed as

AdolescentAdultAnticonvulsantsBody WeightDose-Response Relationship, DrugFemaleHumansLevetiracetamMalePhenytoinSingle-Blind MethodStatus EpilepticusTreatment OutcomeValproic AcidYoung AdultAnticonvulsantsfosphenytoinLevetiracetamPhenytoinValproic Acidantiseizure medicationsdose-responseESETTseizure cessationweight-based dosing

Identifiers

PMID32420641
PMCPMC9282679
OpenAlexW3027205916

What OpenQuestion holds

Textmetadata
LicenceTDM
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.