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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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