| CTRI Number |
CTRI/2026/04/109183 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early Prediction of ICU Mortality Using Clinical Variables and a Novel Oxygenation–Lactate Ratio |
|
Scientific Title of Study
|
Early Prediction of ICU Mortality Using Age, Physiological Variables, and a Novel PaO2 by FiO2 divided by Lactate Ratio A Prospective Observational 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 |
Swathi JR |
| Designation |
DrNB resident |
| Affiliation |
Manipal Hospital |
| Address |
department of critical care medicine 6th floor Manipal Hospital Millers Road Millers Road Opposite to St Annes College Vasanth Nagar Bengaluru
Bangalore
KARNATAKA
560052
India |
| Phone |
8971844952 |
| Fax |
|
| Email |
swathijr477@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swathi JR |
| Designation |
DrNB resident |
| Affiliation |
Manipal Hospital |
| Address |
department of critical care medicine 6th floor Manipal Hospital Millers Road Millers Road Opposite to St Annes College Vasanth Nagar Bengaluru
Bangalore
KARNATAKA
560052
India |
| Phone |
8971844952 |
| Fax |
|
| Email |
swathijr477@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi JR |
| Designation |
DrNB resident |
| Affiliation |
Manipal Hospital |
| Address |
department of critical care medicine 6th floor
Manipal Hospital Millers Road Millers Road Opposite to St Annes College Vasanth Nagar Bengaluru
Bangalore
KARNATAKA
560052
India |
| Phone |
8971844952 |
| Fax |
|
| Email |
swathijr477@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
manipal hospital |
| Address |
department of critical care medicine 6th floor
Manipal Hospital Millers Road Millers Road Opposite to St Annes College Vasanth Nagar 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 SHARATH |
MANIPAL HOSPTAL |
6TH FLOOR DEPARTMENT OF CRITICAL CARE MEDICINE
Manipal Hospital Millers Road Millers Road Opposite to St Annes College Vasanth Nagar Bengaluru
Bangalore
KARNATAKA |
9663783860
sharath.gouda@manipalhospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF MANIPAL HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.01 Year(s) |
| Age To |
99.99 Year(s) |
| Gender |
Both |
| Details |
Admitted to ICU more than twelve hours
Age more than eighteen years
|
|
| ExclusionCriteria |
| Details |
Admitted to ICU less than twelve hrs.
Age less than eighteen yrs.
Elective surgery Post operative patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ICU mortality |
till ICU admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To validate nine selected clinical and laboratory parameters and develop a scoring system using these parameters to predict ICU mortality at admission and aiming to assist in grading patients for risk stratification aiding clinical decision making at the time of ICU admission |
at admission to ICU |
| To evaluate the relationship of the above parameters with ICU length of stay |
at admission to ICU |
| To determine their association with organ support requirements mechanical ventilation, vasopressors, renal replacement therapy. |
on admission to ICU |
| To assess repeat ICU admission during the same hospitalization as an indicator of subsequent clinical deterioration |
on adimission to ICU |
| To identify independent predictors of ICU outcomes using multivariate logistic regression analysis |
on admission to ICU |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
10/06/2026 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Early prediction of mortality in critically ill patients is essential for timely intervention and optimal resource utilization in the Intensive Care Unit Commonly used scoring systems such as APACHE two and SOFA Score require multiple variables and extended observation periods limiting rapid risk assessment at admission This prospective observational cohort study aims to evaluate the association between admission parameters age mean arterial pressure Glasgow Coma Scale platelet count INR serum creatinine urine output per kg arterial pH and the PaO2 by FiO2 divided by lactate ratio and ICU mortality Adult ICU patients will be enrolled and data collected within 24 hours of admission The primary outcome is ICU mortality with secondary outcomes including ICU length of stay and organ support requirements |