| CTRI Number |
CTRI/2021/04/032782 [Registered on: 13/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of frailty in patients getting admitted to ICU and effect on clinical outcome |
|
Scientific Title of Study
|
Prevalence of frailty and its effect on requirement of organ support and clinical outcomes in critically ill patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhananjay Kumar Singh |
| Designation |
Senior Resident |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7897454604 |
| Fax |
|
| Email |
dr.dhananjay17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeru Sahni |
| Designation |
Associate Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009005 |
| Fax |
|
| Email |
neerunalin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhananjay Kumar Singh |
| Designation |
Senior Resident |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7897454604 |
| Fax |
|
| Email |
dr.dhananjay17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care
PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Depaartment Of Anaesthesia and Intensive Care |
| Address |
PGIMER, Chandigarh |
| 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 |
| Dhananjay Kumar Singh |
PGIMER |
4th Floor
Department of Anaesthesia and Intensive Care
Nehru Hospital
PGIMER
Chandigarh
CHANDIGARH |
7897454604
dr.dhananjay17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,PGIMER,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients getting admitted to Main Intensive Care Unit |
|
| ExclusionCriteria |
| Details |
1. Death within 24 hours of ICU admission
2. Admission for palliation and organ donation
3. Patient could not be interviewed and proxy not available
4. Patients leaving against medical advice. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of frailty |
Within 24 hour of admission to ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mechanical ventilation
Vasoactive support
Renal replacement therapy
ICU mortality
ICU length of stay
Hospital mortality
Hospital length of stay
30 day mortality
Hospital acquired infection |
1. Throughout ICU and Hospital stay
2. 30 days after discharge from hospital
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "317"
Final Enrollment numbers achieved (India)="317" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2021 |
| Date of Study Completion (India) |
16/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 newer concept of assessing a patient’s vulnerability to adverse clinical outcomes taking into account the clinical and sociodemographic factors. It has got a multifactorial etiology that may help to identify vulnerable patients in various healthcare settings. The present study is intended to find out the prevalence of frail patients in critical care settings . The patients of age more than 13 years that are admitted to main intensive care unit of PGIMER, Chandigarh will be divided into two groups depending on the score of 5 on Clinical Frailty Scale(CFS). The frail group of patients having CFS more than or equal to 5 will be compared to non-frail patients with CFS less than 5. The primary outcome of the study is to find out the prevalence of frailty in critically ill patients. The secondary aim will be to compare the two groups on the requirement of organ support therapies as well as other variables e.g. ICU and Hospital mortality, ICU and Hospital length of stay, Hospital acquired infection and 30 days mortality. |