Evidence map›Paper›PMID 38812049›Full record

Trial reportTrials2024

Seizure control via pH manipulation: a phase II double-blind randomised controlled trial of inhaled carbogen as adjunctive treatment of paediatric convulsive status epilepticus (Carbogen for Status Epilepticus in Children Trial (CRESCENT)).

Rob Forsyth, Maria Allen, Emma Bedson, Alice Downes, Chris Gough, Stuart Hartshorn, Kelly Lawton, Mark D Lyttle, Shrouk Messahel, Niall Mullen and 7 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Review
  2. 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

17 authors.

Rob ForsythNewcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK. rob.forsyth@newcastle.ac.uk.ORCID http://orcid.org/0000-0002-5657-4180
Maria AllenNewcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
Emma BedsonLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
Alice DownesLeeds Teaching Hospitals NHS Trust, Leeds, UK.
Chris GoughNottingham University Hospitals NHS Trust, Nottingham, UK.
Stuart HartshornBirmingham Children's Hospital NHS Trust, Birmingham, UK.
Kelly Lawton, Newcastle upon Tyne, UK.
Mark D LyttleEmergency Department, Bristol Royal Hospital for Children, Bristol, UK.
Shrouk MessahelAlder Hey Children's NHS Foundation Trust, Liverpool, UK.
Niall MullenSunderland and South Tyneside NHS Foundation Trust, Sunderland, UK.
Joseph RaperNewcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
Anna Rosala-HarrisLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
Leigh TaggartLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
Jason UrronNewcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
Emily WaltonUniversity Hospitals Sussex NHS Foundation Trust, Worthing, UK.
Carrol GambleLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) collaborative

Funding

Efficacy and Mechanism Evaluation Programme NIHR129875
6 · The paper itself

Abstract

backgroundPaediatric convulsive status epilepticus is the most common neurological emergency presenting to emergency departments. Risks of resultant neurological morbidity and mortality increase with seizure duration. If the seizure fails to stop within defined time-windows, standard care follows an algorithm of stepwise escalation to more intensive treatments, ultimately resorting to induction of general anaesthesia and ventilation. Additionally, ventilatory support may also be required to treat respiratory depression, a common unwanted effect of treatment. There is strong pre-clinical evidence that pH (acid-base balance) is an important determinant of seizure commencement and cessation, with seizures tending to start under alkaline conditions and terminate under acidic conditions. These mechanisms may be particularly important in febrile status epilepticus: prolonged fever-related seizures which predominantly affect very young children. This trial will assess whether imposition of mild respiratory acidosis by manipulation of inhaled medical gas improves response rates to first-line medical treatment.

methodsA double-blind, placebo-controlled trial of pH manipulation as an adjunct to standard medical treatment of convulsive status epilepticus in children. The control arm receives standard medical management whilst inhaling 100% oxygen; the active arm receives standard medical management whilst inhaling a commercially available mixture of 95% oxygen, 5% carbon dioxide known as 'carbogen'. Due to the urgent need to treat the seizure, deferred consent is used. The primary outcome is success of first-line treatment in seizure cessation. Planned subgroup analyses will be undertaken for febrile and non-febrile seizures. Secondary outcomes include rates of induction of general anaesthesia, admission to intensive care, adverse events, and 30-day mortality. DISCUSSION: If safe and effective 95% oxygen, 5% carbon dioxide may be an important adjunct in the management of convulsive status epilepticus with potential for pre-hospital use by paramedics, families, and school staff.

trial registrationEudraCT: 2021-005367-49. CTA: 17136/0300/001. ISRCTN: 52731862. Registered on July 2022.

Indexed as

Carbon DioxideStatus EpilepticusAcid-Base EquilibriumAcidosis, RespiratoryAdministration, InhalationChildChild, PreschoolDouble-Blind MethodFemaleHumansHydrogen-Ion ConcentrationInfantMaleOxygenSeizures, FebrileTreatment OutcomecarbogenCarbon DioxideOxygenAcid–baseConvulsive status epilepticusDeferred consentPaediatricspHRespiratory acidosis

Identifiers

PMID38812049
PMCPMC11135009

What OpenQuestion holds

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Registered trials

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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.