| CTRI Number |
CTRI/2021/02/031503 [Registered on: 23/02/2021] Trial Registered Prospectively |
| Last Modified On: |
03/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Frailty among intensive care patients and its impact on clinical outcomes |
|
Scientific Title of Study
|
Frailty among critically ill patients in India: Prevalence and association with patient-centered outcomes |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharath Kumar Tirupakuzhi Vijayaraghavan |
| Designation |
Consultant |
| Affiliation |
Apollo Hospitals, Chennai, India |
| Address |
Department of Critical Care Medicine, 2nd Floor, Apollo Main Hospital, 21 Greams Lane, Chennai, India
Greams Road
Chennai
TAMIL NADU
600004
India |
| Phone |
9591100655 |
| Fax |
|
| Email |
bharath@icuconsultants.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bharath Kumar Tirupakuzhi Vijayaraghavan |
| Designation |
Consultant |
| Affiliation |
Apollo Hospitals, Chennai, India |
| Address |
Department of Critical Care Medicine, 2nd Floor, Apollo Main Hospital, 21 Greams Lane, Chennai, India
Greams Road
Chennai
TAMIL NADU
600004
India |
| Phone |
9591100655 |
| Fax |
|
| Email |
bharath@icuconsultants.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharath Kumar Tirupakuzhi Vijayaraghavan |
| Designation |
Consultant |
| Affiliation |
Apollo Hospitals, Chennai, India |
| Address |
Department of Critical Care Medicine, 2nd Floor, Apollo Main Hospital, 21 Greams Lane, Chennai, India
Greams Road
Chennai
TAMIL NADU
600004
India |
| Phone |
9591100655 |
| Fax |
|
| Email |
bharath@icuconsultants.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals Educational and Research Foundation- no monetary support |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Educational and Research Foundation |
| Address |
2nd Floor, Krishnadeep Chambers, Number 1, Wallace Garden, Chennai- 600006 |
| 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 |
| Bharath Kumar Tirupakuzhi Vijayaraghavan |
Apollo Main Hospital |
Department of Critical Care Medicine, Apollo Main Hospital, 2nd Floor, 21 Greams Lane, Chennai
Chennai
TAMIL NADU |
9591100655
bharath@icuconsultants.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
There is no intervention. But the exposure group is frail patients |
Nil |
| Comparator Agent |
There is no interventon- but the comparator group is non-frail patients |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
Adult critically ill patients ( age more than or equal to 18 and upto 99 years)
Admitted to the ICU
|
|
| ExclusionCriteria |
| Details |
If length of stay is less than 48hrs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of frailty at the time of ICU admission |
Prevalence of frailty at the time of ICU admission (i.e. day 1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between frailty and ICU mortality up to28days |
28 days |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
Final Enrollment numbers achieved (Total)= "838"
Final Enrollment numbers achieved (India)="838" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2021 |
| Date of Study Completion (India) |
26/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Trial yet to start |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Email the PI: bharath@icuconsultants.com with a sound proposal
- For how long will this data be available start date provided 01-01-2023 and end date provided 31-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Our prospective registry-embedded observational study will evaluate the prevalence of frailty at ICU admission and test the association between admission frailty and ICU outcomes. We will include all adult critically ill patients admitted to the ICU during the study period. Our estimated sample size is 800 and study duration is 2 years.
Objectives:
1.
Quantify the prevalence of frailty
among critically ill adults admitted to 4 ICUs.
2.
Quantify the association between
frailty and ICU mortality
3.
Determine factors associated with
frailty
Research
Questions:
Among critically ill adults admitted to 4
intensive care units in India:
1.
What is the prevalence of frailty?
2.
Is there an association between
frailty and ICU mortality?
3.
What factors are associated with
frailty at ICU admission?
Inclusion Criteria: -
Adult patients (≥ 18 years old) -
Admitted to the intensive care unit
from the emergency room/ or from the inpatient ward -
Exclusion criteria: Lack of
informed consent
Statistical
Analysis: Hypotheses: Frailty
is associated with worse outcomes, specifically higher ICU mortality. Null hypothesis: There is
no difference between the frail and non-frail in ICU mortality. Alternate hypothesis:
There is a difference between frail and non-frail critically ill patients in
ICU mortality.
Sample size and power: Based on data from high-income countries, the
prevalence of frailty is ranges from 25 to 30%.4,7 There is no data
on the prevalence of frailty among critically ill patients in India. One study
from the community documented a prevalence of 26%5. In feasibility
work led by us (unpublished data), the total proportion of vulnerable (11%) and
frail patients (8%) was 19%. For the purposes of sample size calculation, we
will hence assume a prevalence of frailty of 10%. In our setting, baseline mortality is
20%. For sample size calculation we
assumed that the risk is 15% higher in the frail cohort (i.e. 35% would die).
We set the significance level to 5% and the type 2 error at 10%.
Based on this framework, we estimated a
desired sample size of 720 patients. Assuming a 10% loss to follow-up, we
inflated our sample size to 800 patients.
Analytic approach: We will report categorical variables as
percentages and continuous variables as mean ± SD or median and IQR (for skewed
data). We will describe the prevalence of frailty in our cohort. We will
analyse the association between frailty and mortality using a chi square test
and develop a multivariable logistic regression model to adjust for potential
confounders. All analyses will be two-tailed and will be performed using Stata
14. For analysis of risk factors associated with
frailty, candidate variables were chosen based on previous research or based on
biological and contextual probability. Stepwise logistic regression will be
performed to select independent predictors of frailty in this cohort.
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