UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058473 |
|---|---|
| Receipt number | R000066858 |
| Scientific Title | Benzodiazepines as first-line treatment for status epilepticus in adults: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/15 15:28:42 |
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Basic information
Public title
Benzodiazepines as first-line treatment for status epilepticus in adults: A systematic review and meta-analysis
Acronym
Benzodiazepines as first-line treatment for status epilepticus in adults: A systematic review and meta-analysis
Scientific Title
Benzodiazepines as first-line treatment for status epilepticus in adults: A systematic review and meta-analysis
Scientific Title:Acronym
Benzodiazepines as first-line treatment for status epilepticus in adults: A systematic review and meta-analysis
Region
| Japan |
Condition
Condition
status epilepticus
Classification by specialty
| Emergency medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate which benzodiazepine should be used as the first-line treatment for status epilepticus in adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality, clinical seizure cessation, poor neurological outcome, endotracheal intubation, seizure recurrence.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Randomized controlled trials (RCTs)
2) Studies involving patients with status epilepticus
3) Studies evaluating acute-phase treatment using lorazepam, midazolam, or diazepam, from initial emergency care through intensive care unit (ICU) management
4) English or Japanese
Key exclusion criteria
Conference abstract
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Eisei |
| Middle name | |
| Last name | Hoshiyama |
Organization
Dokkyo Medical University
Division name
Department of Neurology and Emergency and Critical Care Center
Zip code
3210293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Japan
TEL
0282861111
eisei@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Eisei |
| Middle name | |
| Last name | Hoshiyama |
Organization
Dokkyo Medical University
Division name
Department of Neurology and Emergency and Critical Care Center
Zip code
3210293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Japan
TEL
0282861111
Homepage URL
eisei@dokkyomed.ac.jp
Sponsor or person
Institute
Guideline committee of Japan Resuscitation Council (Neuroresuscitation)
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Japan
Tel
0282861111
eisei@dokkyomed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Database
We will use the PubMed, Cochrane Library databases, and ICHUSHI as database.
Data extraction
For each included study, data will be extracted on the first author, year of publication, number of participating centers, number of patients, age, sex, mortality, and seizure cessation.
Risk of bias assessment
We will assess risk of bias using RoB2.
Strategy for data synthesis
We will perform the meta-analysis (random effect) using RevMan software.
Management information
Registered date
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066858
