| CTRI Number |
CTRI/2025/12/099852 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting the outcome of critically ill patients in intensive care unit using Modified NUTRIC score(mNUTRIC score) |
|
Scientific Title of Study
|
Predicting the outcome of critically ill patients in intensive care unit using Modified NUTRIC score(mNUTRIC score)- 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 |
Pratheeksha N P |
| Designation |
Junior Resident |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of anaesthesiology Rajarajeshwari medical college and hospital, kambipura,Mysore road, Banglore, karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9591392955 |
| Fax |
|
| Email |
drpratheekshaprakash98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sowmya M J |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology Rajrajeshwari medical college and hospital, kambipura, Mysore Road, Banglore, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sowmya M J |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology Rajrajeshwari medical college and hospital, kambipura, Mysore Road, Banglore, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJARAJESHWARI MEDICAL COLLEGE AND HOSPITAL, 202, Mysore Rd, Kengeri Satellite Town, Kambipura, Bengaluru, Karnataka 560074 |
|
|
Primary Sponsor
|
| Name |
Pratheeksha N.P |
| Address |
RAJARAJESHWARI MEDICAL COLLEGE AND HOSPITAL, 202, Mysore Rd, Kengeri Satellite Town, Kambipura, Bengaluru, Karnataka 560074 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| PRATHEEKSHA N P |
Rajarajeshwari medical college and hospital |
2nd floor department of Anaesthesia kambipura, Mysore road, Banglore karnataka 560074
Bangalore
KARNATAKA |
9591392955
drpratheekshaprakash98@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
patients aged 18-85 years admitted in multidiscplinary ICU who are critically ill. |
|
| ExclusionCriteria |
| Details |
1.Patients who are discharged within 24 hours after ICU admission.
2.Death within 24hours
3.Burns and post cardiac surgery patients.
4.Patients discharged against medical advice.
5.Not willing to provide written informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To Evaluate the accuracy of mNUTRIC score in predicting mortality of critically ill patients in ICU by finding the cutoff point using ROC curve for a period of 24 months. |
1. To Evaluate the accuracy of mNUTRIC score in predicting mortality of critically ill patients in ICU by finding the cutoff point using ROC curve for a period of 24 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to evaluate the accuracy of mNUTRIC score in predicting mortality of crtically ill patients in ICU 2.To calculate sensitivity & specificity, Positive predictive value (PPV) & Negative predictive value (NPV) of mNUTRIC score over a peroid of 24 months.
3. To assess the Length of Stay (LOS) in ICU for a period of 24 months. |
length of stay in ICU |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
04/01/2026 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Predictig the outcome of critically ill patients in the intensive care unit using modified NUTRIC (mNUTRIC) score - A prospective observationa; study |