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Article Dans Une Revue Critical care (London, England) Année : 2023

Valproic acid as adjuvant treatment for convulsive status epilepticus: a randomised clinical trial

1 Centre Hospitalier Sainte Anne [Paris]
2 IPNP - U1266 Inserm - Institut de psychiatrie et neurosciences de Paris
3 Hôpital Hôtel-Dieu [Paris]
4 CRESS (U1153 / UMR_A 1125) - Centre for Research in Epidemiology and Statistics | Centre de Recherche Épidémiologie et Statistiques
5 CHU Angers - Centre Hospitalier Universitaire d'Angers
6 CESP - Centre de recherche en épidémiologie et santé des populations
7 Hôpital Ambroise Paré [AP-HP]
8 Centre hospitalier Félix-Guyon [Saint-Denis, La Réunion]
9 Hôpital Edouard Herriot [CHU - HCL]
10 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
11 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
12 UL - Université de Lorraine
13 Hôpital de Hautepierre [Strasbourg]
14 HUS - Les Hôpitaux Universitaires de Strasbourg
15 Hôpital de Châlons-en-Champagne
16 CHU Saint-Antoine [AP-HP]
17 SU - Sorbonne Université
18 Hôpital Robert Ballanger [Aulnay-sous-Bois]
19 Centre Hospitalier René Dubos [Pontoise]
20 IAME (UMR_S_1137 / U1137) - Infection, Anti-microbiens, Modélisation, Evolution
21 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
22 Centre Hospitalier d'Etampes
23 ICM - Institut du Cerveau = Paris Brain Institute
24 CHU Pitié-Salpêtrière [AP-HP]
25 Perception et Mémoire / Perception and Memory
26 2I - Infection et inflammation
27 Hôpital Raymond Poincaré [Garches]
28 UVSQ - Université de Versailles Saint-Quentin-en-Yvelines
29 Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy]
Pierre Asfar

Résumé

BACKGROUND: Generalised convulsive status epilepticus (GCSE) is a medical emergency. Guidelines recommend a stepwise strategy of benzodiazepines followed by a second-line anti-seizure medicine (ASM). However, GCSE is uncontrolled in 20-40% patients and is associated with protracted hospitalisation, disability, and mortality. The objective was to determine whether valproic acid (VPA) as complementary treatment to the stepwise strategy improves the outcomes of patients with de novo established GCSE. METHODS: This was a multicentre, double-blind, randomised controlled trial in 244 adults admitted to intensive care units for GCSE in 16 French hospitals between 2013 and 2018. Patients received standard care of benzodiazepine and a second-line ASM (except VPA). Intervention patients received a 30 mg/kg VPA loading dose, then a 1 mg/kg/h 12 h infusion, whilst the placebo group received an identical intravenous administration of 0.9% saline as a bolus and continuous infusion. Primary outcome was proportion of patients discharged from hospital by day 15. The secondary outcomes were seizure control, adverse events, and cognition at day 90. RESULTS: A total of 126 (52%) and 118 (48%) patients were included in the VPA and placebo groups. 224 (93%) and 227 (93%) received a first-line and a second-line ASM before VPA or placebo infusion. There was no between-group difference for patients hospital-discharged at day 15 [VPA, 77 (61%) versus placebo, 72 (61%), adjusted relative risk 1.04; 95% confidence interval (0.89-1.19); p = 0.58]. There were no between-group differences for secondary outcomes. CONCLUSIONS: VPA added to the recommended strategy for adult GCSE is well tolerated but did not increase the proportion of patients hospital-discharged by day 15. TRIAL REGISTRATION NO: NCT01791868 (ClinicalTrials.gov registry), registered: 15 February 2012.
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Dates et versions

hal-03949580 , version 1 (11-02-2023)

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Tarek Sharshar, Raphaël Porcher, Pierre Asfar, Lamiae Grimaldi, Julien Jabot, et al.. Valproic acid as adjuvant treatment for convulsive status epilepticus: a randomised clinical trial. Critical care (London, England), 2023, 27 (1), ⟨10.1186/s13054-022-04292-7⟩. ⟨hal-03949580⟩
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