| CTRI Number |
CTRI/2021/07/035216 [Registered on: 28/07/2021] Trial Registered Prospectively |
| Last Modified On: |
27/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Study of ICU acquired psychosis in patients admitted in ICU |
|
Scientific Title of Study
|
PREVALENCE OF DELIRIUM IN MEDICAL ICU:A Prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Ranjan Pattanayak |
| Designation |
DrNB resident (doctor) |
| Affiliation |
Fortis Escorts Heart Institute,Okhla road,New Delhi |
| Address |
Critical Care Medicine Department, Fortis Escorts Heart Institute,Okhla road,New Delhi
South
DELHI
110025
India |
| Phone |
08093868718 |
| Fax |
|
| Email |
rashmipattanayak88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajat Agrawal |
| Designation |
Head of the department,critical care medicine, FEHI, New Delhi |
| Affiliation |
Fortis Escorts Heart Institute,Okhla road,New Delhi |
| Address |
Critical Care Medicine Department, Fortis Escorts Heart Institute,Okhla road,New Delhi
South
DELHI
110025
India |
| Phone |
9818851504 |
| Fax |
|
| Email |
rajat.agarawal@fortishealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Agrawal |
| Designation |
Head of the department,critical care medicine, FEHI, New Delhi |
| Affiliation |
Fortis Escorts Heart Institute,Okhla road,New Delhi |
| Address |
Critical Care Medicine Department, Fortis Escorts Heart Institute,Okhla road,New Delhi
South
DELHI
110025
India |
| Phone |
9818851504 |
| Fax |
|
| Email |
rajat.agarawal@fortishealthcare.com |
|
|
Source of Monetary or Material Support
|
| Fortis Escorts Heart Institute, Okhla Road, New Delhi |
|
|
Primary Sponsor
|
| Name |
Fortis Escorts Heart Institute |
| Address |
Fortis Escorts Heart Institute, Okhla Road, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 |
| Rashmi Ranjan Pattanayak |
Fortis Escorts Heart Institute, |
Critical Care Medicine Department,ICU-1,ground floor
South
DELHI |
08093868718
rashmipattanayak88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Fortis Escorts Heart Institute,Okhla Road,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted to medical icu |
|
| ExclusionCriteria |
| Details |
History of psychosis.
History of neurological disease like CVA and epilepsy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of delirium by CAM-ICU |
Assessed daily for 10 days or till discharge whichever earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment given after delirium assessment, length of icu stay, length of hospital stay |
Assessed daily for 10 days or till discharge whichever earlier |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/07/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My study is a prospective observational study to assess prevalence of delirium in our medical icu. I will use CAM ICU method to assess delirium daily in our icu. After delirium assessment I will use medicine to treat delirium and then I will assess how it will affect icu stay and hospital stay. |