| CTRI Number |
CTRI/2023/06/053573 [Registered on: 06/06/2023] Trial Registered Prospectively |
| Last Modified On: |
05/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
DELIRIUM IN MEDICAL INTENSIVE CARE UNITS : INCIDENCE, RISK FACTORS, TYPES AND OUTCOME |
|
Scientific Title of Study
|
A STUDY OF INCIDENCE, SUBTYPES, ASSOCIATED RISK FACTORS AND OUTCOME OF DELIRIUM AMONG PATIENTS ADMITTED IN MEDICAL INTENSIVE CARE UNITS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JASANI VRAJESH ANILBHAI |
| Designation |
Junior Resident |
| Affiliation |
GCS Medical College Hospital Research Centre |
| Address |
GCS Medical College, Hospital and Research Centre, Naroda road, Ahmedabad.
Ahmadabad
GUJARAT
380025
India |
| Phone |
8460263922 |
| Fax |
|
| Email |
drvrajesh.jasani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ALPESH GEDIYA |
| Designation |
PROFESSOR |
| Affiliation |
GCS Medical College Hospital Research Centre |
| Address |
GCS Medical College Hospital and Research Centre naroda road Ahmedabad Gujarat
Ahmadabad
GUJARAT
380025
India |
| Phone |
09909919369 |
| Fax |
|
| Email |
alpeshgediya84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JASANI VRAJESH ANILBHAI |
| Designation |
Junior Resident |
| Affiliation |
GCS Medical College Hospital Research Centre |
| Address |
GCS Medical College Hospital and Research Centre NARODA ROAD Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
8460263922 |
| Fax |
|
| Email |
drvrajesh.jasani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
| Address |
GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| JASANI VRAJESH ANILBHAI |
GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
MEDICAL ICU ,10 TH FLOOR , GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025
Ahmadabad
GUJARAT |
8460263922
drvrajesh.jasani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients (consecutive sampling)
aged 18 to 65 years admitted to the medical ICU. |
|
| ExclusionCriteria |
| Details |
1. Were delirious at the time of admission.
2. Comatose throughout their ICU stay.
3. Severely aphasic interfering with assessment.
4. Not willing to consent (proxy or self). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 100 CONSECUTIVE PATIENT WILL ASSESSED AND THROUGH OUT THERE STAY IN ICU THEY WILL BE ASSESSED FOR CAUSE , TYPES, ON WHICH DAY DELIRIUM IS DEVELOPED |
ON 2ND DAY OF ADMISSION, FOLLOWED BY FOLLOW UP ON EVERY DAY TILL DELIRIUM DEVELOPS OR PT DISCHARGE. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OUTCOME IS SEEN AT THE TIME OF DISCHARGE OR MORTALITY |
OBSERED AT THE TIME OF DISCHARGE |
|
|
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)
|
13/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present trail will be
prospective and observational in design will find out incidence and
subtype of delirium. It will also be able to correlate risk factors
associated in development of delirium in patients admitted in medical
intensive care units and also clinical outcome of patient with delirium. |