| CTRI Number |
CTRI/2025/08/093348 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Intensive Care Unit admission in Young Adults (18- 40 years) |
|
Scientific Title of Study
|
Clinical profile and outcomes of young adults (18- 40 years) admitted to the ICU: A Prospective Cohort study |
| Trial Acronym |
YOUNG ADULTS- ICU |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/NEW/INST/2023/TN/0293 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Jessica Janet |
| Designation |
Critical Care Technologist |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No. 29 (4) East Tank Street, Nandambakkam, Chennai
Thiruvallur TAMIL NADU 600089 India |
| Phone |
7550035785 |
| Fax |
|
| Email |
jessijeni19@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
S Jessica Janet |
| Designation |
Critical Care Technologist |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No. 29 (4) East Tank Street, Nandambakkam, Chennai
Thiruvallur TAMIL NADU 600089 India |
| Phone |
7550035785 |
| Fax |
|
| Email |
jessijeni19@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
S Jessica Janet |
| Designation |
Critical Care Technologist |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No. 29 (4) East Tank Street, Nandambakkam, Chennai
Thiruvallur TAMIL NADU 600089 India |
| Phone |
7550035785 |
| Fax |
|
| Email |
jessijeni19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai- 600116 |
| 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 S Velmurugan |
Sriramachandra Institute of Higher Education and Research |
Department of Critical Care Medicine, SRIHER(DU), Porur, Chennai-600116 Thiruvallur TAMIL NADU |
9968859560
dr.velsri86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T814||Infection following a procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 40 years.
Admitted to ICU for greater than or equal to 24 hours during the study period. |
|
| ExclusionCriteria |
| Details |
ICU re- admissions during the same hospitalization (only the first admission will be considered). Patients or relatives who decline to provide informed consent (if required by IEC). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ICU mortality rate among young adults |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Length of ICU stay
Need of organ support
Complications rates
Predictors of poor outcomes
Hospital discharge status |
One year |
|
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
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)
|
31/08/2025 |
| 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="1" 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
|
Young adults, typically aged 18 to 40 years, are generally considered to be in good health. However, this age group is increasingly encountering severe illnesses and injuries that require admission to intensive care units (ICUs). In India, trauma, severe infections (including sepsis), acute poisoning, and exacerbations of chronic diseases are among the leading causes of ICU admission in this population. Although younger patients often have fewer comorbidities and better physiological reserves compared to older patients, they are not immune to poor outcomes, including death and long-term disability.Despite the growing need to understand critical illness in young adults, most studies in the critical care literature focus predominantly on the elderly. Many ICU outcome studies aggregate adult data without stratifying by age, potentially obscuring age-specific trends and risk factors. Furthermore, data from high-income countries may not be directly applicable to the Indian context, where the disease burden, healthcare-seeking behaviour, and resource availability differ significantly. Given these gaps, there is a need for well-designed, prospective studies that focus specifically on young adults in the ICU. This study aims to prospectively evaluate the clinical characteristics, treatment interventions, and outcomes of patients aged 18–40 years admitted to the ICU over a one-year period. Findings from this study will provide valuable insights into risk stratification, treatment planning, and prognosis in this under-researched group. |