| CTRI Number |
CTRI/2025/11/098146 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
APACHE II severity score to assess risk of death in patients after cardiac arrest |
|
Scientific Title of Study
|
Dynamic APACHE II score to predict the outcome of post cardiac arrest patients in Intensive care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan Raj P |
| Designation |
DrNB fellow |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and Anesthesiology ICU 7 8 9 10 11 12
Gurgaon
HARYANA
122001
India |
| Phone |
09943333636 |
| Fax |
|
| Email |
drmohanrajpalanisamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Raj P |
| Designation |
DrNB fellow |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and Anesthesiology ICU 7 8 9 10 11 12
Gurgaon
HARYANA
122001
India |
| Phone |
09943333636 |
| Fax |
|
| Email |
drmohanrajpalanisamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Raj P |
| Designation |
DrNB fellow |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and Anesthesiology ICU 7 8 9 10 11 12
Gurgaon
HARYANA
122001
India |
| Phone |
09943333636 |
| Fax |
|
| Email |
drmohanrajpalanisamy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mohan Raj P |
| Address |
Medanta The Medicity |
| Type of Sponsor |
Other [Self] |
|
|
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 Mohan Raj P |
MEDANTA - THE MEDICITY |
Institute of Critical Care and Anesthesiology ICU 7 8 9 10 11 12
Gurgaon
HARYANA |
09943333636
drmohanrajpalanisamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients age greater than 18 years
2 Patients receiving Targeted Temperature Management after ROSC
|
|
| ExclusionCriteria |
| Details |
1 Pregnancy
2 Cardiac arrest due to hypovolemic shock by trauma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In hospital mortality of the post cardiac arrest patients |
Till hospital Discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cerebral Performance Category or CPC Score |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Acute physiological assessment and chronic health estimation II ( APACHE II) score was designed as a mortality predictor tool. It is generally calculated using worst laboratory and clinical parameters recorded within 24 hours of ICU admission. There is limited evidence on application APACHE II Score in post CPR patients in ICU. The study aims to evaluate the performance of dynamic APACHE II score on consecutive days after CPR to predict the outcome of patients. |