| CTRI Number |
CTRI/2024/05/067855 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Prophylactic antiseizure medication in post cardiac arrest children |
|
Scientific Title of Study
|
Role of prophylactic Levetiracetam on seizure prevention in children during post CPR recovery phase -A Randomized(Double Blinded)Controlled Trial |
| Trial Acronym |
REAP trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raju S M |
| Designation |
Pediatric Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences,Raipur |
| Address |
Pediatric Intensive Care Unit (2 C3 Ward), C block 2nd floor
Department of Pediatrics
All India Institute Of Medical Sciences
Raipur
Gate No1 Great Eastern Road
AIIMS campus
Tatibandh
Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9844777197 |
| Fax |
|
| Email |
smraju457@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Atul Jindal |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences,Raipur |
| Address |
Pediatric Intensive Care Unit (2 C3 Ward)
Department of Pediatrics
All India Institute Of Medical Sciences
Raipur
Gate No1 Great Eastern Road
AIIMS campus
Tatibandh
Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8224014667 |
| Fax |
|
| Email |
dratuljindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raju S M |
| Designation |
Pediatric Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences,Raipur |
| Address |
Pediatric Intensive Care Unit (2 C3 Ward)
Department of Pediatrics
All India Institute Of Medical Sciences
Raipur
Gate No1 Great Eastern Road
AIIMS campus
Tatibandh
Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9844777197 |
| Fax |
|
| Email |
smraju457@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Raipur
Gate no 1 , Great eastern Road , Opposite gurudwara , AIIMS campus, Tatibandh , Raipur , Chhattisgarh 492099 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
All India Institute Of Medical Sciences,Raipur
Gate No1, Great Eastern Rd,opposite Gurudwara,AIIMS campus, Tatibandh, Raipur, chattisgarh 492099 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrRaju S M |
AIIMS,Raipur |
Pediatric Intensive Care Unit(PICU), 2C3 ward , C block 2nd floor , Department of Pediatrics
Gate no 1 , Great eastern road, opposite Gurudwara, AIIMS campus , Tatibandh, Raipur, Chattisgarh 492099
Raipur
CHHATTISGARH |
9844777197
smraju457@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee, All India Institute of Medical Sciences, Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj.Levetiracetam |
Inj.Levetiracetam 40mg/kg IV loading dose followed by 20mg/kg/day in 2 divided doses Intravenous route for 7 days. |
| Comparator Agent |
Normal Saline |
Equal volume of Normal Saline |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All children between age of 1 month to 15 years who had cardiac arrest and undergone CPR after Return Of Spontaneous Circulation (ROSC) with hemodynamic stability |
|
| ExclusionCriteria |
| Details |
1) Brain dead children
2) The children with known seizure disorder on antiepileptic medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| occurence of seizures |
during post CPR recovery phase till discharge from hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Seizure pattern, duration of encephalopathy,organ dysfunction ,mortality and morbidity |
till discharge
follow up after 30 days and 90 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The children between 1-month to ≤ 15 years of age, who have undergone CPR will be considered for the study. Hemodynamic stability would be achieved and patient details, course cause for cardio-pulmonary arrest will be documented. The participants will be randomized into two groups based on the computer-generated process i.e., prophylactic and the conventional group. The children in the prophylactic group will be started on antiepileptic medication which will be pre-labelled as drug X or Y and the principal investigator will be blinded from the drugused. Inj. Levetiracetam 40mg/kg/dose and followed by 20mg/kg/day in two divided doses within 30 minutes after hemodynamic stabilization and the children in the conventional group would be given equal volume of saline. The participants will be closely monitored for 7 days via EEG (electroencephalogram) and antiepileptic medication other than Levetiracetam will be initiated if they develop any clinical or non-clinical seizures as per physician discretion. The nursing staff will be taught and informed about giving drug X and drug Y in both the groups. Both the medications pre-labelled as X and Y required for study will be prepared apriori from the hospital pharmacy. If the patient doesn’t meet the inclusion criteria they would be excluded. If the child survives up to discharge, will be followed up after 30 days and 90 days.After the study is complete, the data will be recorded in Excel sheet and analysis will be performed using intention to treat process using latest SPSS version. |