| CTRI Number |
CTRI/2024/07/070921 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to find after effects related to performance conditions in patients after treatment of cardiac arrest who are already admitted in neurosurgery ICU. |
|
Scientific Title of Study
|
NeuRological outcomE of patients after cardiac arreST in neurOcritical care unit: The RESTORE Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akhil M S |
| Designation |
Senior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE, NEW DELHI |
| Address |
Department of Neuroanaesthesia and critical care, CN center, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9497690408 |
| Fax |
|
| Email |
akhilms8024293@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Kapoor |
| Designation |
Additional professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Department of Neuroanaesthesia and critical care, CN center, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9013439134 |
| Fax |
|
| Email |
Dr.indu.me@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akhil M S |
| Designation |
Senior resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Department of Neuroanaesthesia and critical care, AIIMS, NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9497690408 |
| Fax |
|
| Email |
akhilms8024293@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences, New Delhi, India, pin.110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical sciences New Delhi |
| Address |
Department of neuroanaesthesia and critical care, AIIMS, New Delhi, 110029. |
| 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 |
| Dr AKHIL M S |
All India Institute of Medical Sciences |
Room no-604,Department of Neuroanaesthesia and critical care, CN center, AIIMS, Ansari Nagar, New
Delhi, 110029
South
DELHI |
9497690408
akhilms8024293@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS , New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Written informed consent from relative / attendant
2.All neurosurgical and neurological critically ill patients who achieve reversal of spontaneous circulation [ROSC]after in-hospital cardiac arrest |
|
| ExclusionCriteria |
| Details |
Patient does not achieve ROSC after cardiac arrest
Out of hospital cardiac arrest with ROSC
AGE less than 18 years
Non consenting relative or attendant |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Neurological outcome assessed using Glasgow outcome scale extended at 3 and 6 months
2. Factors (demographic and disease related) affecting the outcome of patients at 3 and 6 months. |
1. at 3 and 6 months
2. Factors assessment at 1st hr, 24hr, and 5th day post ROSC
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Consciousness assessment at 1 hour, 24 hour and 5th day post ROSC ( assessed using GCS-P) |
At 1 hour, 24 hour, 5th day post ROSC |
| Post cardiac arrest complications |
At hospital stay period, 3 months and 6 months post ROSC |
| ICU length of stay |
Duration of ICU stay |
| Hospital length of stay |
Duration of hospital admission |
| Mortality |
Till 6th month post ROSC |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/07/2024 |
| Date of Study Completion (India) |
26/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Cardiac arrest is a major health problem, with a yearly incidence of about 50-110 per 100000 people worldwide. The brain is prone to injury even during short periods of limited blood flow. Thus the most frequent cause of morbidity and mortality after cardiac arrest is neurologic injury. This becomes more significant in neurocritical care ICU where there is already patients suffering from brain insult. Hypoxia and ischemia sustained by the brain during arrest causes an injury cascade that may include excitotoxicity, disrupted calcium homeostasis, free radical formation and pathologic protease pathways,which are associated with cell death and neurological dysfunction. A majority of patients who are resuscitated after cardiac arrest and survive intensive care; have some neurological impairments that can range from mild cognitive deficit to coma. Sudden cardiac arrest accounts for 15-20 % of all the deaths in the general population and timely cardio-pulmonary resuscitation (CPR) improves survival rate by three to four times. In indian studies in-hospital cardiac arrest survival rate ranges from 6.9 to 27.5%. There is no definite consensus on what represents a poor neurological outcome after a cardiac arrest. The timing of neurological outcome assessment also affects its measured values, since in initially comatose cardiac arrest survivor’s neurological status can improve for upto 6 months. Optimal time for assessment of neurological outcome after cardiac arrest have yet to be established. Cardiac arrest is a catastrophic event with higher morbidity and mortality rate. The neurological injury post cardiac arrest is more devastating to the patient as well as to the family. The vast majority of persons successfully resuscitated from cardiac arrest are initially comatose due to hypoxic ischemic encephalopathy. Later depending on the patient’s condition, it can progress to improvement, worsening neurological outcome or even death. We planned this study to find out the neurological outcome of patients after in-hospital cardiac arrest admitted in our neurocritical care unit. |