| CTRI Number |
CTRI/2025/09/095449 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Finding the Best Way to Spot Malnutrition in Seriously Sick ICU Patients |
|
Scientific Title of Study
|
Global Leadership Initiative on Malnutrition (GLIM) versus Subjective Global Assessment in Detecting Malnutrition and Predicting Outcomes 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 |
Manoj Kumar R |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
New ICU,Father Mullers Medical College,Kankanady,Mangalore,Karnataka Dakshina Kannada KARNATAKA 575002 India |
| Phone |
08807651423 |
| Fax |
|
| Email |
manovignes@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vijay Sundarsingh Subbiah |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Medical College |
| Address |
New ICU,Father Mullers Medical College,Kankanady,Mangalore,Karnataka
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
08072952625 |
| Fax |
|
| Email |
vijayss87pm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vijay Sundarsingh Subbiah |
| Designation |
Associate Professor |
| Affiliation |
Father Muller Medical College |
| Address |
New ICU,Father Mullers Medical College,Kankanday,Mangalore,Karnataka
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
08072952625 |
| Fax |
|
| Email |
vijayss87pm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father muller medical college |
|
|
Primary Sponsor
|
| Name |
MANOJ KUMAR R |
| Address |
room no 205, mullers nest, jeppu, |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 Manoj Kumar R |
Father Muller Medical College |
New ICU,Father Muller Medical College,Kankanady,Mangalore,Karnataka Dakshina Kannada KARNATAKA |
08807651423
manovignes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Mullers Institutional Ethics Committee |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- Age more than 18 years
- ICU stay is anticipated to be more than 48 hours
- Availability of complete clinical data (e.g., APACHE II and SOFA scores), anthropometric measurements (height, weight, BMI), and laboratory parameters (such as CRP) required to apply GLIM, SGA, NRS-2002, and mNUTRIC criteria.
|
|
| ExclusionCriteria |
| Details |
- Pregnant or lactating women
- ICU readmission during the same hospital stay
- Incomplete or missing data that preclude the application of nutritional assessment tools
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the diagnostic performance of GLIM criteria (alone and in combination with NRS-2002 and mNUTRIC) for identifying malnutrition in critically ill ICU patients, using Subjective Global Assessment (SGA) as the reference standard. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the prevalence of malnutrition identified by GLIM, GLIM + NRS-2002, and GLIM + mNUTRIC.
2. To evaluate the agreement between each diagnostic method (GLIM, GLIM + NRS-2002, and GLIM + mNUTRIC) and the Subjective Global Assessment (SGA), used as the reference standard.
3. To compare the predictive validity of GLIM, GLIM + NRS-2002, and GLIM + mNUTRIC with ICU outcomes:
a. ICU length of stay
b. ICU and 28-day mortality
c. Duration of mechanical ventilation
d. Duration of Vasopressor requirement
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2025 |
| 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 Yet Recruiting |
| 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
|
Malnutrition is highly prevalent among critically ill patients admitted to intensive care units (ICUs) and is strongly associated with poor clinical outcomes including prolonged ICU stay, increased duration of mechanical ventilation, higher risk of infections, and increased mortality. Accurately diagnosing malnutrition early in these patients is essential to initiate timely nutritional interventions and improve clinical outcomes. Traditionally, the Subjective Global Assessment (SGA) has been the reference standard tool for diagnosing malnutrition in hospitalized patients. However, the SGA has limitations in ICU settings, where patients are often sedated, mechanically ventilated, or unable to provide their clinical history, reducing its applicability and accuracy. The Global Leadership Initiative on Malnutrition (GLIM) criteria, developed in 2018, offer a new consensus framework for diagnosing malnutrition through a two-step process: first identification of nutritional risk, followed by diagnosis using phenotypic criteria (such as weight loss, low BMI, or reduced muscle mass) combined with etiologic criteria (such as reduced food intake or inflammation). Recent research suggests that combining GLIM criteria with validated nutritional risk screening tools like Nutritional Risk Screening 2002 (NRS-2002) and modified Nutrition Risk in Critically Ill (mNUTRIC) score enhances the detection and prognostic accuracy of malnutrition in ICU patients. This prospective observational study conducted in the Indian ICU setting aims to compare the diagnostic accuracy and predictive validity of GLIM alone, GLIM combined with NRS-2002, and GLIM combined with mNUTRIC against SGA. The study will also evaluate the prevalence of malnutrition detected by these tools and their ability to predict important ICU outcomes, including length of stay, duration of mechanical ventilation, vasopressor use, and mortality. The findings will provide critical data to validate and optimize malnutrition assessment protocols in critically ill Indian patients and support better clinical decision-making toward personalized nutritional support in critical care. |