Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus

Xuanwu Hospital, Beijing120 enrolled

Overview

Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency, evidence-based data to guide initial drug treatment choices are lacking in the Chinese population. The investigators conduct this prospective randomized controlled trial to evaluate the relative efficacy and safety of intravenous (IV) phenobarbital (PB) and valproate (VPA) in patients with GCSE.

After the failure of first-line diazepam treatment, patients with GCSE are randomized to receive either IV PB (standard doses, low rate) or VPA (standard). Successful treatment is considered when clinical and electroencephalographic seizure activity ceases. Adverse events following treatment and the neurological outcomes at discharge and 3 months later are also evaluated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Generalized Convulsive Status Epilepticus

Interventions

PhenobarbitalDRUG

In the PB group, a loading dose of 20 mg/kg (may give an additional 10 mg/kg) begins at a rate of 50 mg/min followed by IV 100 mg q6 h.

ValproateDRUG

In the VPA group, a loading dose of 30 mg/kg (may give an additional 15 mg/kg) begins at a rate of 3 mg/kg per min followed by a continuous infusion at a rate of 1-2 mg/kg per hour.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All consecutive GCSE patients (after the failure of first-line diazepam treatment) who were admitted in the emergency room or neurocritical care unit in Xuanwu Hospital of Capital Medical University. Exclusion Criteria: * Unstable vital signs, such as a systolic blood pressure of \<90 mm Hg, a pulse of \<60 beats per min, or an arterial blood oxygen saturation of \<90%, * Liver dysfunction (alanine transaminase or total bilirubin of more than twice the normal upper limit), * Neurologic emergency requiring immediate surgical intervention, * Pregnancy or breast feeding, * Hypersensitivity to study drugs.

Locations (6)

Xuanwu Hospital

Beijing, Beijing Municipality, China

RECRUITING

Zhongshan Hospital, Xiamen University

Xiamen, Fujian, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Number of patients with effective seizure control

The primary study endpoint is the number of patients with effective seizure control, defined as a cessation of clinical and electroencephalographic seizure activity within 1 h after administration of the phenobarbital or valproate loading dose. Effective control of GCSE is assessed clinically by one certified neurologist and also confirmed with EEG by one certified electroencephalographer.

Time frame: One hour after the end of the PB or VPA loading dose

Secondary Outcomes

Mortality of patients

Neurologic outcome is assessed both at 30 days and at 3 months by one physician unaware of the therapeutic assignment through a phone interview or scheduled follow-up clinic visit. Mortality of each group is recorded at 30 days and at 3 months, respectively.

Time frame: at 30 days and at 3 months

Number of patients with post-SE symptomatic epilepsy

Post-SE symptomatic epilepsy at 3 months is analyzed. It is defined as the occurrence of at least 2 unprovoked epileptic seizure occurring not earlier than 4 weeks after termination of SE in those without pre-existing epilepsy.

Time frame: 3 months

The relapse rates of SE and nonconvulsive status epilepticus (NCSE) / nonconvulsive seizures (NCS)

The investigators also record the relapse rates of SE and nonconvulsive status epilepticus (NCSE) / nonconvulsive seizures (NCS) in each group in the first 24 h.

Time frame: in the first 24 h

Central Contacts

Su Yingying

CONTACT

15901361953 tangsuyingying@sina.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.