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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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