| CTRI Number |
CTRI/2025/05/087434 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Early Detection of Sepsis in Adult ICU Patients Using Machine Learning Techniques at a University Medical College Hospital |
|
Scientific Title of Study
|
Early Detection of Sepsis in Adult ICU Patients Using Machine Learning Techniques at a University Medical College Hospital |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHAGYASHREE MOHANTY |
| Designation |
PhD Scholar Department of Critical Care and Medicine |
| Affiliation |
Institute of Medical Sciences and Sum Hospital , Siksha O Anusandhan Deemed to be University |
| Address |
Department of Critical Care Medicine, Institute of Medical Sciences and Sum Hospital, Siksha ‘O’ Anusandhan Deemed to be University, K8, Kalinga Nagar, Bhubaneswar-751003, Odisha, India
Baleshwar
ORISSA
India |
| Phone |
7854011149 |
| Fax |
|
| Email |
mohanty.bhagyashree25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sanghamitra Mishra |
| Designation |
Dean and Professor, Department of Critical Care and Medicine |
| Affiliation |
Institute of Medical Sciences and Sum Hospital , Siksha O Anusandhan Deemed to be University |
| Address |
Institute of Medical Sciences and Sum Hospital, Sector-8, Kalinganagar,Ghatikia, Bhubaneswar-751030
Khordha
ORISSA
751030
India |
| Phone |
7381177222 |
| Fax |
|
| Email |
dean.ims@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sanghamitra Mishra |
| Designation |
Dean and Professor |
| Affiliation |
Institute of Medical Sciences and Sum Hospital , Siksha O Anusandhan Deemed to be University |
| Address |
Institute of Medical Sciences and Sum Hospital, Sector 8, Kalinganagar, Ghatikia, Bhubaneswar-751030
Koraput
ORISSA
751030
India |
| Phone |
7381177222 |
| Fax |
|
| Email |
bimamishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences and Sum Hospital, Siksha ‘O’ Anusandhan Deemed to be University |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences and Sum Hospital, Siksha ‘O’ Anusandhan Deemed to be University |
| Address |
Institute of Medical Sciences and Sum Hospital, Siksha ‘O’ Anusandhan Deemed to be University, Sector-8, Kalinganagar, Ghatikia, Bhubaneswar-751030 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| BHAGYASHREE MOHANTY |
Institute of Medical Sciences and Sum Hospital , Siksha O Anusandhan Deemed to be University |
Sector-8,Ghatikia, Kalinganagar, Bhubanesar-751030
Khordha
ORISSA |
7854011149
mohanty.bhagyashree25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Medical Sciences and SUM Hospital, Siksha O Anusandhan Deemed to be University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients age 18 or greater than 18 years.
(2) Infection at the time of admission to the ICU.
|
|
| ExclusionCriteria |
| Details |
(i) Patients are known to be pregnant and lactating women.
(iii) Patients with missing data will be excluded from the analysis.
(iv) Patients already septic at ICU admission.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early detection of sepsis |
15 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The risk factors associated with sepsis |
15 months |
|
|
Target Sample Size
|
Total Sample Size="667"
Sample Size from India="667"
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)
|
05/06/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Yet not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is an observational, single-center study aimed at developing and validating machine learning models for the early prediction of sepsis in adult ICU patients using real-time clinical data. The study includes approximately 667 patients from tertiary care hospitals in India. By analyzing routinely collected parameters such as vital signs, lab values, and clinical history, the model seeks to predict sepsis within 6 hours of ICU admission. The goal is to improve early diagnosis, reduce ICU mortality, and enhance clinical decision-making. The study is expected to provide a clinically applicable Machine learning tool tailored to the Indian healthcare context. |