Generalized Convulsive Status Epilepticus Clinical Trial
Official title:
Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus in Adults: A Prospective Randomized Controlled Trial in China
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital | Beijing | Beijing |
China | Xiangya Hospital, Central South University | Changsha | Hunan |
China | Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
China | The First People's Hospital of Yunnan Province | Kunming | Yunnan |
China | Xijing Hospital | Shanxi | Xi'an |
China | Zhongshan Hospital, Xiamen University | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Adverse Events | Adverse events are recorded as follows: systolic blood pressure lower than 90 mmHg, pulse lower than 50 beats/ min, arrhythmia (except supraventricular tachycardia), respiratory depression (arterial oxygen saturation below 90%, partial pressure of oxygen below 60 mmHg, or partial pressure of carbon dioxide above 60 mmHg), drug-induced liver disease (alanine aminotransferase or total bilirubin increase of more than twice the upper limit of the normal range), elevation of blood ammonia (more than twice the upper limit of the normal range), gastric motility insufficiency, bone marrow suppression (leukocytopenia, neutrocytopenia, thrombocytopenia or anemia), coagulation disorders, or drug-related sedation. The time to record adverse events is from the administration of PB or VPA to 1 week. | From the administration of PB or VPA to 1 week | |
Primary | 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. | One hour after the end of the PB or VPA loading dose | |
Secondary | 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. | at 30 days and at 3 months | |
Secondary | 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. | 3 months | |
Secondary | 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. | in the first 24 h |
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