| CTRI Number |
CTRI/2014/10/005141 [Registered on: 24/10/2014] Trial Registered Retrospectively |
| Last Modified On: |
22/05/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to note the effects of three drugs, phenytoin, valproate and levetiracetam in patients with convulsive status epilepticus |
|
Scientific Title of Study
|
Efficacy of parenteral phenytoin, valproate and levetiracetam in the treatment of convulsive status epilepticus: a randomized controlled study |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjib Sinha |
| Designation |
Additional Prof of Neurology |
| Affiliation |
NIMHANS |
| Address |
National Institute of Mental Health and Neuro Sciences,
Hosur road,
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995150 |
| Fax |
08026564830 |
| Email |
sanjib_sinha2004@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mundlamuri Ravindranath Chowdary |
| Designation |
DM (Neurology) Final year resident NIMHANS, Bangalore, India |
| Affiliation |
NIMHANS |
| Address |
National Institute of Mental Health and Neuro Sciences,
Hosur road,
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995150 |
| Fax |
08026564830 |
| Email |
mundlamuri.ravi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Sinha |
| Designation |
Additional Prof of Neurology |
| Affiliation |
NIMHANS |
| Address |
National Institute of Mental Health and Neuro Sciences,
Hosur road,
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995150 |
| Fax |
08026564830 |
| Email |
sanjib_sinha2004@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NON FUNDED |
| Address |
NOT Appilicable |
| Type of Sponsor |
Other [NON-FUNDED TRIAL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjib Sinha |
Emergency services, Dept of Neurology, NIMHANS, Bangalore, India |
Dept of Neurology,
NIMHANS, Hosur Road
Bangalore
Bangalore
KARNATAKA |
08026995150
08026564830
sanjib_sinha2004@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with convulsive status epilepticus. Recruited patients received i.v. lorazepam within 5 min. of arrival to the emergency services and then randomized into 3 groups., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levetiracetam |
group 3: The LEV group received intravenous levetiracetam (Levepil) - 25 mg/kg (1000-2000 mg) over 30 minutes followed by maintenance dose of 25mg /kg/day in 3 divided doses. |
| Intervention |
Phenytoin |
group 1: The PHT group received intravenous phenytoin sodium (Epsolin) - 20 mg/kg (800-1600 mg) in 100 ml normal saline infused immediately at a rate of 50 mg/minute followed by maintenance dose of 5mg/kg/day in 3 divided doses. |
| Intervention |
Sodium Valproate |
group 2: The SVA group received intravenous sodium valproate (Encorate) - 30 mg/kg (1200-2400 mg) in 100 ml normal saline infused over 15 minutes followed by maintenance dose of 30mg/kg /day in 3 divided doses. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Consecutive patients presented to NIMHANS emergency services with convulsive SE (more than 30 minutes of continuous convulsive seizure activity or two or more sequential seizures without full recovery of consciousness in between seizures)
2. All underlying etiology of SE
3.All the 150 recruited patients with GCSE received intravenous lorazepam (0.1 mg/kg; 4-6 mg) within 5 minutes of arrival to the emergency services.
4.consented for the study
5.age group between 15-65 years were included |
|
| ExclusionCriteria |
| Details |
unwilling patients, patients presenting with non-convulsive SE, liver failure, renal failure, cardiac disease, pregnancy, requiring urgent neurosurgical intervention, H/O allergy to drugs, patients treated outside with AEDs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome was seizure control |
Control of SE: a) No recurrence of seizures after 30 minutes of AED infusion with substantial improvement in sensorium over next 24 hours; or b) Sensorium did not improve substantially but EEG excluded NCSE. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes were mortality, morbidity, side effects, and seizure control at 1 month |
at discharge from hospital and at 1 month |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
To be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Status epilepticus (SE) is a one of the neurological emergency with significant mortality and morbidity. The AEDs currently approved for management of SE after the usage of benzodiazepine, are phenytoin, fosphenytoin, sodium valproate cannot be administered often in patients with hepatic, renal or cardiac dysfunctions and most of these AEDs have potential drug interactions with concurrent AEDs or other medications. For the last few years, intravenous levetiracetam have been introduced in clinical practice and it has shown promising results in various retrospective studies. There are no systematic RCT comparing phenytoin, sodium valproate and levetiracetam after administering lorazepam in patients with generalized convulsive SE (GCSE). As per the current guidelines, once SE is refractory i.e. not controlled with benzodiazepines and another AED i.e. either phenytoin or valproate, it is advised to provide an ICU care with ventilator, with anaesthetic agents like midazolam, thiopentone or propofol. The benefits of such early treatment is unquestionable. But, the problems are non-availability of ventilatory ICU beds especially in resource poor settings like India; higher incidence of ICU infections; and anaesthetic medication induced side effects. Moreover, there is no definite evidence that aggressive treatment with anaesthetic agents in refractory SE will improve the outcome. Therefore, this prospective study was conducted as a randomised controlled study to compare the efficacy of phenytoin, valproate sodium and levetiracetam along with lorazepam as first line in patients with GCSE at this centre. |