FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/098983 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 11/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Outcomes of elderly patients admitted to intensive care unit in India 
Scientific Title of Study   Outcomes of elderly patients admitted to intensive care unit and their association with frailty scores - a cohort study. 
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 Rajesh Mohan Shetty 
Designation  Consultant in Intensive care 
Affiliation  Manipal Hospital Whitefield 
Address  1st floor, Intensive care unit office, Manipal hospital whitefield, Opposite nexus shantiniketan, Bengaluru

Bangalore
KARNATAKA
560066
India 
Phone  8861926929  
Fax    
Email  rajeshshetty@manipalhospitals.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ashwin Neelavar Udupa 
Designation  Consultant in intensive care 
Affiliation  Manipal hospital 
Address  Intensive care office, 2nd floor, Manipal hospital kanakapura road, Bangalore

Bangalore
KARNATAKA
560062
India 
Phone  08861926929  
Fax    
Email  ashwinudupa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ashwin Neelavar Udupa 
Designation  Consultant in intensive care 
Affiliation  Manipal hospital 
Address  Intensive care office, 2nd floor, Manipal hospital kanakapura road, Bangalore

Bangalore
KARNATAKA
560062
India 
Phone  08861926929  
Fax    
Email  ashwinudupa@gmail.com  
 
Source of Monetary or Material Support  
Intensive care department, 1st floor, Manipal hospital whitefield, opp nexus shanthinikethan, Bengaluru 
 
Primary Sponsor  
Name  Manipal hospital whitefield 
Address  1st floor, Intensive care department, Manipal hospital whitefield, opp nexus shanthiniketan, bengaluru 
Type of Sponsor  Private hospital/clinic 
 
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 Rajesh Mohan Shetty  Manipal Hospital Whitefield  1st floor, Intensive care department office, Manipal Hospital Whitefield Opp prestige shanthinikethan bengaluru
Bangalore
KARNATAKA 
9886660477

rajeshshetty@manipalhospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manipal hospitals ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J410||Simple chronic bronchitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age more than 65 years 
 
ExclusionCriteria 
Details  Refusal of consent
No legal guardian available to give consent

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Hospital mortality  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Length of stay in ICU readmission to ICU hospital LOS escalation of care events including – renal replacement therapy vasopressors inotropes invasive mechanical ventilation  two years 
 
Target Sample Size   Total Sample Size="900"
Sample Size from India="900" 
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)   22/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/12/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Outcomes of elderly patients admitted to intensive care unit and their association with frailty scores  a cohort study

Background

With increase in the survival age in the last 100 years number and proportion of elderly patients admitted to ICU has increased and so has the patients diagnosed with frailty The average global population aged 65 years is currently close to 85 and is expected to be nearly 16 by 2050 Global estimates of frailty range from 35 to 27 In India incidence of frailty is between 1540 in the hospitals caring for older adults 1 Assessment of morbidities among elderly patients admitted to ICU the diagnosis of frailty and their course in the hospital has implications for assignment of resources in the hospital as well as the communities On literature review we found only one prospective registryembedded cohort study 2 on the outcomes of elderly patients admitted to Indian ICUs Hence we would like to conduct this cohort study where elderly patients defined chronologically by age above 65 years will be included in the study They would be assessed for presence of frailty using Clinical frailty score CFS 3 which is the commonest frailty score used in the ICU 4 They will be followed up for hospital outcomes and escalation of care until discharge The primary aim of this study is to describe the epidemiology of elderly ICU patients We would also like to compare the outcomes between elderly frail and nonfrail patients 

Methodology
This will be a prospective observational multicentre study on the cohort of elderly patients admitted to the ICU We expect the study duration to be around two years No treatment modifications will be made based on the CFS assignment of these elderly patients All patients admitted to ICU aged 65 years will be assessed for frailty using the Rockford frailty scores also known as clinical frailty score CFS 3 CFS will be assigned at the participating ICUs based on the history from the patient or the relative Study coordinators will be identified at every participating centres and online training will be provided on the assignment of CFS using the examples and standard image templates Baseline comorbidities of included patients will be recorded Their medication history will be recorded All patient related information will be entered into the online patient information database Indian Registry of Intensive Care  IRIS Maintaining confidentiality and data protection of all the patient related information will be as per the security protocol managed by the IRIS platform
Our primary outcome will be hospital mortality The secondary outcomes will be Length of stay LOS in ICU readmission to ICU hospital LOS escalation of care events including  renal replacement therapy RRT vasopressorsinotropes invasive mechanical ventilation and others
Inclusion criteria
Elderly patients above 65 years of age admitted to ICU
Exclusion criteria
1 No legal guardian available to give consent
2 Refusal of consent

Statistical analyses 
The enrolled patients will be classified into CFS 14 Very fit to vulnerable defined as nonfrail vs CFS 58 mild Frailty to very severe frailty defined as frail for the purpose of analysis Based on survey of previous literature 2 for an outcome variable on mortality rate in two groups of patients in ICU with minimum difference of 50  to attain significance at type I error   error of at least 5 Type II error  error of 10 and keeping statistical power above 90 the estimated sample size is 900 for two  group assessment clinical study after adjusting for losttofollow up dropout rates and withdrawal of consent 5 The data collection will be carried out until the predetermined sample size is reached The statistical methods ChiSquare test Fisher exact test student t test or any other suitable method will be employed at the time of data analysis as appropriate

References

1 Chatterjee P Understanding Frailty The Science and Beyond in Health and Wellbeing in Late Life Perspectives and Narratives from India ed Chatterjee P 120

2 Tirupakuzhi Vijayaraghavan BK Rashan A Ranganathan L Venkataraman R Tripathy S Jayakumar D et al IRIS collaborative Prevalence of frailty and association with patient centered outcomes A prospective registryembedded cohort study from India J Crit Care 2024 Apr80154509 

3 Rockwood K Song X MacKnight C et alA global clinical measure of fitness and frailty in elderly people CMAJ 2005 173 489495

4 Darvall JN Bellomo R Paul E Subramaniam A Santamaria JD Bagshaw SM Rai S Hubbard RE and Pilcher D 2019 Frailty in very old critically ill patients in Australia and New Zealand a populationbased cohort study Med J Aust 211 318323



 
Close