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CTRI Number  CTRI/2025/01/079288 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A Study on Quadriceps Muscle Thickness, Frailty, and Health Outcomes in ICU Patients Over 50 Years 
Scientific Title of Study   Assessment of Quadriceps Muscle Layer Thickness trajectory and its association with Preadmission Frailty, comorbidities, and Mortality in Critically Ill Patients aged more than 50 years admitted in the ICU: 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  Dr VIJAY SUNDARSINGH SUBBIAH 
Designation  Associate professor 
Affiliation  FATHER MULLERS MEDICAL COLLEGE HOSPITAL 
Address  Department of Critical Care Medicine,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
Scientific Query  
Name  Dr VIJAY SUNDARSINGH SUBBIAH 
Designation  Associate professor 
Affiliation  FATHER MULLERS MEDICAL COLLEGE HOSPITAL 
Address  Department of Critical Care Medicine,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 MANOJ KUMAR R 
Designation  Assistant professor 
Affiliation  FATHER MULLERS MEDICAL COLLEGE HOSPITAL 
Address  Department of Critical care Medicine, New ICU, Father Mullers Medical College Hospital,Kankanday,Mangalore,Karnataka, India - 575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  08807651423  
Fax    
Email  manovignes@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Father Muller Medical College 
Address  FATHER MULLERS MEDICAL COLLEGE,KANKANADY,MANGALORE,KARNATAKA,INDIA. PIN -575002 
Type of Sponsor  Private medical college 
 
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 MULLERS MEDICAL COLLEGE   NEW ICU,FATHER MULLERS 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: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - Patients aged more than 50 years.
- Admitted to the ICU.
- Expected ICU stay of more than 96 hours.
 
 
ExclusionCriteria 
Details  - Patients who are pregnant.
- Patients anticipated to have a poor prognosis or who choose to discontinue life-sustaining treatment.
- Patients with amputated or injured lower limbs.
- Patients with bilateral deep vein thrombosis.
- Patients who stayed in the hospital for more than 5 days in the past 2 weeks.
- Patients not ambulating independently before the illness leading to ICU admission (unable to walk more than 15m without stopping, with or without gait aid).
- Patients with pre-existing primary systemic neuromuscular diseases (acute or chronic presentation).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association of the change in QMLT from baseline to day 4, day 7, and at hospital discharge with frailty, co-morbidities, and mortality in critically ill patients aged over 50 years admitted to the ICU.  At Baseline, 4th day, 7th day and at hospital discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Association of organ supports & other outcomes (ventilator-free days, vasopressor-free days, Requirement of RRT, RRT-free days, LOS ICU, LOS Hospital) with
a. Changes in QMLT (from baseline to day 4, day 7, & at hospital discharge)
b. Frailty status
c. Comorbidity status
d. Baseline nutritional status
 		 At Baseline, 4th day, 7th day & at hospital discharge 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/02/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This prospective, single-center observational study aims to evaluate the trajectory of Quadriceps Muscle Layer Thickness (QMLT) during the first week of ICU admission and its association with preadmission frailty, comorbidities, and mortality in critically ill patients aged over 50 years. Frailty, assessed using the Clinical Frailty Scale (CFS), is a known predictor of poor outcomes in ICU patients. Sarcopenia, closely linked to frailty, further compounds vulnerability and impairs recovery.

The study will include 40 patients admitted to the ICU with an expected stay exceeding 96 hours. Baseline QMLT will be measured via bedside ultrasonography on day 1, followed by repeat measurements on days 4, 7, and at hospital discharge. Associations between QMLT changes and clinical frailty, comorbidity-polypharmacy scores, and mortality will be analyzed. Secondary outcomes, including ventilator-free days, vasopressor-free days, renal replacement therapy (RRT) use, ICU/hospital length of stay, and infection rates, will also be evaluated.

This research seeks to identify the utility of QMLT as a dynamic marker of critical illness progression and its relationship with frailty and comorbid conditions. Findings may guide early interventions and tailored care strategies for critically ill adults, enhancing outcomes and resource optimization in ICUs.

 
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