| CTRI Number |
CTRI/2021/01/030562 [Registered on: 19/01/2021] Trial Registered Prospectively |
| Last Modified On: |
18/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the association of frailty in patients admitted to critical care unit and to study the their outcomes. |
|
Scientific Title of Study
|
Association of frailty with outcomes in critically ill elderly patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRKalaiselvan |
| Designation |
DRNB SUPERSPECIALITY RESIDENT |
| Affiliation |
ABVIMS & DR RML HOSPITAL |
| Address |
ROOM NO 202, TRAUMA BUILDING SECOND FLOOR ,Department of critical care medicine, ABVIMS & DR RML HOSPITAL. Baba Kharak Singh Rd, Connaught Place, New Delhi, Delhi 110001
Central
DELHI
110001
India |
| Phone |
01123404699 |
| Fax |
|
| Email |
kalaiselvan.m.s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRKalaiselvan |
| Designation |
DRNB SUPERSPECIALITY RESIDENT |
| Affiliation |
ABVIMS & DR RML HOSPITAL |
| Address |
ROOM NO 202, TRAUMA BUILDING SECOND FLOOR ,Department of critical care medicine, ABVIMS & DR RML HOSPITAL. Baba Kharak Singh Rd, Connaught Place, New Delhi, Delhi 110001
Central
DELHI
110001
India |
| Phone |
01123404699 |
| Fax |
|
| Email |
kalaiselvan.m.s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRKalaiselvan |
| Designation |
DRNB SUPERSPECIALTY RESIDENT |
| Affiliation |
ABVIMS & DR RML HOSPITAL |
| Address |
ROOM NO 202, TRAUMA BUILDING SECOND FLOOR ,Department of critical care medicine, ABVIMS & DR RML HOSPITAL. Baba Kharak Singh Rd, Connaught Place, New Delhi, Delhi 110001
Central
DELHI
110001
India |
| Phone |
01123404699 |
| Fax |
|
| Email |
kalaiselvan.m.s@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS & DR RMLH HOSPITAL |
|
|
Primary Sponsor
|
| Name |
ABVIMS and DR Ram Manohar Lohia Hospital |
| Address |
ROOM NO 202, TRAUMA BUILDING SECOND FLOOR ,Department of critical care medicine, ABVIMS & DR RML HOSPITAL. Baba Kharak Singh Rd, Connaught Place, New Delhi, Delhi 110001 |
| 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 Amlendu Yadav |
ABVIMS and DRRML hospital. |
ROOM NO 202, TRAUMA BUILDING SECOND FLOOR ,Department of critical care medicine, ABVIMS & DR RML HOSPITAL. Baba Kharak Singh Rd, Connaught Place, New Delhi, Delhi 110001
Central
DELHI |
01123404699
yadavamlendu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical commitee ABVIMS and DR RML hospital. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, (3) ICD-10 Condition: A150||Tuberculosis of lung, (4) ICD-10 Condition: E082||Diabetes mellitus due to underlying condition with kidney complications, (5) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, (6) ICD-10 Condition: K721||Chronic hepatic failure, (7) ICD-10 Condition: N179||Acute kidney failure, unspecified, (8) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (9) ICD-10 Condition: J128||Other viral pneumonia, (10) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 50 years or more admitted to the ICU. will be included in the study. |
|
| ExclusionCriteria |
| Details |
1) Patients expected length of stay less than 24 hours in ICU.
2) Patient readmitted to the ICU
3) No surrogate available.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mortality in frail patients admitted to the ICU
|
28 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Average ICU length of stay
2. Ventilator days
3. Organ failures and organ support provided to patients
|
FROM ICU ADMISSION TO DISCHARGE. |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
20/01/2021 |
| 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="0"
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
|
Frailty, is a state of reduced physical, congnitive and physiological reserve. Frailty has been associated with increased mortalty and morbidity in critically ill patients. This study conducted to find the association of frailty in critically ill patients and its effect on patients outcomes. |