| CTRI Number |
CTRI/2024/09/073935 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
What are the consequences of frailty on outcomes of the critically ill patients |
|
Scientific Title of Study
|
Impact of Frailty on Intensive Care Unit Outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Vadi |
| Designation |
Consultant |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
Near Four Bungalows, Andheri (west)
Mumbai MAHARASHTRA 400053 India |
| Phone |
9090909090 |
| Fax |
|
| Email |
sonalivadi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sonali Vadi |
| Designation |
Consultant |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
Department of Intensive Care Medicine, First floor, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Near Four Bungalows, Andheri (west)
Mumbai MAHARASHTRA 400053 India |
| Phone |
9090909090 |
| Fax |
|
| Email |
sonalivadi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sonali Vadi |
| Designation |
Consultant |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
Department of Intensive Care Medicine, First floor, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Near Four Bungalows, Andheri (west)
Mumbai MAHARASHTRA 400053 India |
| Phone |
9090909090 |
| Fax |
|
| Email |
sonalivadi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Near Four Bungalows, Andheri (west), Mumbai 400053, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
Four Bungalows, Andheri (west), Mumbai, Maharashtra |
| 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 Sonali Vadi |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
Four Bungalows, Andheri (West) Mumbai MAHARASHTRA |
9090909090
sonali.vadi@kokilabenhospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z789||Other specified health status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
none |
none |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
(1) patients aged more than 18 years, (2) medical patients admitted in ICU for more than 48 hours, (3) surgical patients admitted in ICU for more than 5 days |
|
| ExclusionCriteria |
| Details |
(1) readmitted to ICU during index hospitalization, i.e. it would be counted as a single entry, (2) admitted for palliation, (3) inability to evaluate functional, physical, and mental status prior to ICU admission, (4) pre-existing cognitive dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the prevalence and risk factors for frailty in the intensive care unit
2) How frailty in younger adults differs from middle-aged and older adults
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3) To evaluate the impact of frailty on mortality and morbidity in the intensive care unit |
During in-hospital stay |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
13/09/2024 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Frailty is not
the same as aging. Frailty may be a more
reliable indicator of vulnerability than chronological age alone. Frail
individuals may experience catastrophic multisystem organ failure from
illnesses that are tolerated by non-frail individuals of the same age. This can lead to the need for advanced life support in an
intensive care unit (ICU) setting. There is growing evidence that frailty is a common end-of-life
trajectory that extends hospital and ICU stays.
Frailty is
characterized by a decrease in physiologic reserves, making one more vulnerable
to adverse events.1,2 The
risk of frailty is increased by individual chronic diseases or their
co-occurrence. Multiple comorbidities are common among the patients we
manage. The focus should move from
single-condition patient populations to patient populations that are
increasingly complex.3 Risk
factors for frailty include multi-morbidity, polypharmacy, depression,
education, social isolation and loneliness.
Frailty is not linked to age, chronic comorbidities, or disability. Frailty exists on a spectrum. Failure to
thrive is often seen as the end stage of the continuum of frailty. The mortality rate among patients with this
condition is high and their chance of returning home is much lower than that of
typical ICU patients. ICU clinicians need to recognize that the risk of
in-hospital mortality can rapidly change during the initial 2 weeks of an ICU
course. The objective measurement of
frailty can provide more support and reinforcement to clinicians when making
decisions about the appropriateness of ICU support and/or withholding
life-sustaining therapies at the end of life.4,5,6
Frailty, a clinical syndrome that is
characterized by significant vulnerabilities due to declining reserve and
function across multiple physiologic systems, is common in the elderly.7
This study contributes to the growing evidence base that ICU survivorship
places a substantial burden on families and carers, including impaired physical
function, neuropsychological sequelae, increased health care costs and reduced
health-related quality of life.8
As a result, these patients require rehabilitation.9 |