| CTRI Number |
CTRI/2025/06/088188 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Identify Risk Factors Linked to Death in Critically Ill Patients Admitted to Intensive Care Units |
|
Scientific Title of Study
|
An observational study on risk factors for mortality in critically ill patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshini Devi R |
| Designation |
M.Sc. Critical Care Technology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical care Medicine
Sri Ramachandra Institute of higher education and research.
Porur
Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
6385262743 |
| Fax |
|
| Email |
harshramesh25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renuka MK |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Department of Critical care Medicine
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
hod.criticalcare@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renuka MK |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research. Department of Critical care Medicine
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
hod.criticalcare@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai
600116
India. |
|
|
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 600 116 |
| 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 RENUKA MK |
Sri Ramachandra Institute of Higher Education and Research |
Department of Critical care Medicine
Porur
Chennai
TAMIL NADU |
8056126336
hod.criticalcare@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I13||Hypertensive heart and chronic kidney disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients was admitted to the ICU for more than 48 hours during which mortality was recorded.
|
|
| ExclusionCriteria |
| Details |
Patients stayed in the ICU less than 24 hours.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the risk factors for the mortality in the critically ill patients |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of stay in ICU and the need for mechanical ventilation and vasopressors and |
10 months |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
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)
|
16/06/2025 |
| 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="0"
Months="10"
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
|
This observational study aims to identify and analyze risk factors associated with mortality in critically ill patients admitted to the intensive care unit (ICU). Advances in critical care medicine have increased the chances of survival for patients with severe illness or trauma. However, such patients consume a large proportion of medical resources. This study sought risk factors for mortality that have potential to be modified among patients treated in Critical Care Unit.The research focuses on demographic, clinical, and laboratory variables collected at the time of ICU admission and during the hospital stay. By evaluating associations between these factors and patient outcomes, the study seeks to develop insights into predictors of poor prognosis. The findings will contribute to better risk stratification, early intervention strategies, and improved management protocols in critical care settings. The study does not involve any interventional procedure |