دورية أكاديمية
أعرض في EDS

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)).

التفاصيل البيبلوغرافية
العنوان: 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)).
المؤلفون: Forsyth R; Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK. rob.forsyth@newcastle.ac.uk.; Newcastle University, Newcastle Upon Tyne, UK. rob.forsyth@newcastle.ac.uk., Allen M; Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK., Bedson E; Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK., Downes A; Leeds Teaching Hospitals NHS Trust, Leeds, UK., Gough C; Nottingham University Hospitals NHS Trust, Nottingham, UK., Hartshorn S; Birmingham Children's Hospital NHS Trust, Birmingham, UK., Lawton K; Newcastle upon Tyne, UK., Lyttle MD; Emergency Department, Bristol Royal Hospital for Children, Bristol, UK.; Research in Emergency Care Avon Collaborative Hub (REACH), University of the West of England, Bristol, UK., Messahel S; Alder Hey Children's NHS Foundation Trust, Liverpool, UK., Mullen N; Sunderland and South Tyneside NHS Foundation Trust, Sunderland, UK., Raper J; Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK., Rosala-Harris A; Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK., Taggart L; Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK., Urron J; Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK., Walton E; University Hospitals Sussex NHS Foundation Trust, Worthing, UK., Gamble C; Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
مؤلفون مشاركون: Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) collaborative
المصدر: Trials [Trials] 2024 May 29; Vol. 25 (1), pp. 349. Date of Electronic Publication: 2024 May 29.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Carbon Dioxide*/administration & dosage , Carbon Dioxide*/adverse effects , Status Epilepticus*/drug therapy, Child ; Child, Preschool ; Female ; Humans ; Infant ; Male ; Acid-Base Equilibrium/drug effects ; Acidosis, Respiratory/etiology ; Administration, Inhalation ; Double-Blind Method ; Hydrogen-Ion Concentration ; Oxygen ; Seizures, Febrile/drug therapy ; Treatment Outcome
مستخلص: Background: Paediatric 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.
Methods: A 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 Registration: EudraCT: 2021-005367-49. CTA: 17136/0300/001.
Isrctn: 52731862. Registered on July 2022.
(© 2024. The Author(s).)
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معلومات مُعتمدة: NIHR129875 Efficacy and Mechanism Evaluation Programme
فهرسة مساهمة: Investigator: M Tolhurst-Cleaver; S Siner; A Singh; E Ledger; T Harris; R Amos; AJ Downes; S Price; M Mikhail; N Alhashimi
Keywords: Acid–base; Convulsive status epilepticus; Deferred consent; Paediatrics; Respiratory acidosis; pH
المشرفين على المادة: 8063-77-2 (carbogen)
142M471B3J (Carbon Dioxide)
S88TT14065 (Oxygen)
تواريخ الأحداث: Date Created: 20240529 Date Completed: 20240530 Latest Revision: 20240724
رمز التحديث: 20240726
مُعرف محوري في PubMed: PMC11135009
DOI: 10.1186/s13063-024-08188-5
PMID: 38812049
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-024-08188-5