| 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
|
|
|
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
|
|
|
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
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