Evidence map›Paper›PMID 37057711›Full record

ArticleBMJ open2021

The DEXA-CORT trial: study protocol of a randomised placebo-controlled trial of hydrocortisone in patients with brain tumour on the prevention of neuropsychiatric adverse effects caused by perioperative dexamethasone.

Anne-Sophie C A M Koning, Djaina D Satoer, Christiaan H Vinkers, Amir H Zamanipoor Najafabadi, Nienke R Biermasz, Rishi D S Nandoe Tewarie, Wouter A Moojen, Elisabeth F C van Rossum, Clemens M F Dirven, Alberto M Pereira and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
0.5field-weighted citation impact, top 32% 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
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 at 3 institutions in 1 country.

Anne-Sophie C A M KoningDepartment of Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands a.c.a.koning@lumc.nl.ORCID 0000-0001-8809-2576
Djaina D SatoerDepartment of Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands.
Christiaan H VinkersDepartment of Psychiatry (GGZ inGeest), Amsterdam UMC (location VUmc), Vrije University, Amsterdam Public Health and Amsterdam Neuroscience Research Institutes, Amsterdam, The Netherlands.ORCID 0000-0003-3698-0744
Amir H Zamanipoor NajafabadiDepartment of Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospitals, Leiden and The Hague, The Netherlands.ORCID 0000-0003-2400-2070
Nienke R BiermaszDepartment of Medicine, Division of Endocrinology, and Centre for Endocrine Tumors Leiden (CETL), Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0001-5817-3594
Rishi D S Nandoe TewarieDepartment of Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospitals, Leiden and The Hague, The Netherlands.
Wouter A MoojenDepartment of Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospitals, Leiden and The Hague, The Netherlands.
Elisabeth F C van RossumDepartment of Internal Medicine, Division of Endocrinology, Erasmus Medical Center, Rotterdam, The Netherlands.ORCID 0000-0003-0120-4913
Clemens M F DirvenDepartment of Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands.
Alberto M Pereira *Department of Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-1194-9866
Wouter R van Furth *Department of Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center and Haga Teaching Hospitals, Leiden and The Hague, The Netherlands.ORCID 0000-0001-5208-921X
Onno C MeijerDepartment of Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0002-8394-6859
Leiden University Medical Center · NLErasmus MC · NLAmsterdam Neuroscience · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe synthetic glucocorticoid dexamethasone can induce serious neuropsychiatric adverse effects. Dexamethasone activates the glucocorticoid receptor (GR) but, unlike endogenous cortisol, not the mineralocorticoid receptor (MR). Moreover, dexamethasone suppresses cortisol production, thereby eliminating its MR binding. Consequently, GR overactivation combined with MR underactivation may contribute to the neuropsychiatric adverse effects of dexamethasone. The DEXA-CORT trial aims to reactivate the MR using cortisol to reduce neuropsychiatric adverse effects of dexamethasone treatment. METHODS AND ANALYSIS: The DEXA-CORT study is a multicentre, randomised, double-blind, placebo-controlled trial in adult patients who undergo elective brain tumour resection treated perioperatively with high doses of dexamethasone to minimise cerebral oedema. 180 patients are randomised between treatment with either two times per day 10 mg hydrocortisone or placebo during dexamethasone treatment. The primary study outcome is the difference in proportion of patients scoring ≥3 points on at least one of the Brief Psychiatric Rating Scale (BPRS) questions 5 days postoperatively or earlier at discharge. Secondary outcomes are neuropsychiatric symptoms, quality of sleep, health-related quality of life and neurocognitive functioning at several time points postoperatively. Furthermore, neuropsychiatric history, serious adverse events, prescribed (psychiatric) medication and referrals or evaluations of psychiatrist/psychologist and laboratory measurements are assessed. ETHICS AND DISSEMINATION: The study protocol has been approved by the Medical Research Ethics Committee of the Leiden University Medical Center, and by the Dutch competent authority, and by the Institutional Review Boards of the participating sites. It is an investigator-initiated study with financial support by The Netherlands Organisation for Health Research and Development (ZonMw) and the Dutch Brain Foundation. Results of the study will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NL6726 (Netherlands Trial Register); open for patient inclusion. EudraCT number 2017-003705-17.

Indexed as

Brain NeoplasmsHydrocortisoneAdultDexamethasoneDouble-Blind MethodGlucocorticoidsHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeDexamethasoneGlucocorticoidsHydrocortisoneclinical pharmacologyclinical trialsgeneral endocrinologyneurosurgerypsychiatry

Identifiers

PMID37057711
PMCPMC8719188
OpenAlexW4206781185

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.