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CTRI Number  CTRI/2024/08/071832 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 01/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of standard nutrition score with sonography based muscle mass measurement to predict death within 28 days in patients with surgeries on digestive tract 
Scientific Title of Study   Comparison of mNUTRIC score and ultrasound measured upper arm muscle mass as a predictor of 28-day mortality in patients with gastrointestinal surgeries - A prospective cohort 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  SUNMATHY S 
Designation  JUNIOR RESIDENT 
Affiliation  LOKMANYA TILAK MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, 4TH FLOOR, COLLEGE BUILDING, LOKMANYA TILAK MUNICIPAL MEDICALCOLLEGE AND HOSPITAL SION, MUMBAI

Mumbai
MAHARASHTRA
400022
India 
Phone  9791963256  
Fax    
Email  sunmathysubramani172@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR APARNA NERURKAR 
Designation  ADDITIONAL PROFESSOR 
Affiliation  LOKMANYA TILAK MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, 4TH FLOOR, COLLEGE BUILDING, LOKMANYA TILAK MUNICIPAL MEDICALCOLLEGE AND HOSPITAL SION, MUMBAI

Mumbai
MAHARASHTRA
400022
India 
Phone  9833944243  
Fax    
Email  draparnanerurkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR APARNA NERURKAR 
Designation  ADDITIONAL PROFESSOR 
Affiliation  LOKMANYA TILAK MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, 4TH FLOOR, COLLEGE BUILDING, LOKMANYA TILAK MUNICIPAL MEDICALCOLLEGE AND HOSPITAL SION, MUMBAI

Mumbai
MAHARASHTRA
400022
India 
Phone  9833944243  
Fax    
Email  draparnanerurkar@gmail.com  
 
Source of Monetary or Material Support  
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
 
Primary Sponsor  
Name  LOKMANYA TILAK MEDICAL COLLEGE AND HOSPITAL 
Address  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL, SION WEST, MUMBAI 400022 
Type of Sponsor  Government 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 SUNMATHY S  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL, SION WEST,MUMBAI -400022  DEPARTMENT OFA NAESTHESIA,WARD BUILDING,THIRD FLOOR PICCU,SION WEST,MUMBAI-400022
Mumbai
MAHARASHTRA 
9791963256

sunmathysubramani172@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE HUMAN RESEARCH  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, (2) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  USG muscle mass measurement  USG will be used to record upper limb mass on 1st and 5th day during the first five days of postoperative period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.All the patients undergone gastrointestinal surgeries admitted in ICU during postoperative period 
 
ExclusionCriteria 
Details  pregnant patients
patients with primary neuromuscular disorders
patients with bilateral amputated limbs 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
assess mnutric score in postoperative gastrointestinal surgery patients
assess biceps muscle mass by ultrasound
assess 28 day mortality rate
compare the above in predicticting 28 day mortality rate 
28 days 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate effect of feeding practices with change in usg muscle mass and 28 day mortality  28 days 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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   Phase 4 
Date of First Enrollment (India)   12/08/2024 
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)   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  

Nutrition plays a major role in the recovery of patients; mainly in the post operative period. In patients admitted to the Intensive Care Unit (ICU) there is a high chance of malnourishment characterized by prolonged mechanical ventilation and ICU stay with increased morbidity and mortality [1]. Patients who have undergone gastrointestinal surgeries are prone to malnourishment during postoperative period due to alteration in gastric structure and ability to absorb nutrients. [2] There are many guidelines for nutritional assessment which include the American Society for Parenteral and Enteral Nutrition (ASPEN), the Society for Critical Care Medicine, and the European Society for Clinical Nutrition and Metabolism (ESPEN), suggesting early nutritional intervention for patients admitted to a surgical intensive care unit (SICU) [3]. However, studies have reported significant gaps between guidelines and commonly observed practices in surgical patients in intensive care units (ICUs) [4]. In 2011, Heyland et al. [5] developed the Nutrition Risk in the Critically Ill (NUTRIC) score mainly to benefit the patients who have undergone gastrointestinal surgeries. The NUTRIC score has 6 components: Age, Acute Physiology and Chronic Health Evaluation II, Sequential Organ Failure Assessment score, Number of comorbidities, Days from hospital admission to ICU admission, and Serum Interleukin 6 (IL-6). Since IL-6 cannot be assessed on a daily basis the NUTRIC score without serum IL-6 (modified NUTRIC score) was developed by Rahman et al in 2015[6]. Malnutrition is also related to the lean body mass. But the abovementioned scores do not rely upon anthropometry. There are drawbacks using these anthropometric measurements which includes alterations caused by the fluid overload and inflammatory process in critically ill-patients [7]. Such discrepancies led to a need for an easy to perform, accessible technique to assess nutritional status in critically ill patients which is independent of the information given by the patient or caregivers. For this reason, imaging technique has been listed as an important tool in the assessment of lean body mass in postoperative patients amongst which computed tomography (CT SCAN) is the gold standard technique. This technique has major limitations which includes cost, shifting of patients to specific area, expert personnel for study and so on which has made it unreliable as a component for nutritional assessment [8,9]. Hence, CT scan is not a suitable tool for the daily practice [10].  A technique which overcomes these drawbacks would be Ultrasound, an accessible tool in postoperative areas [11]. Various studies have been done on monitoring muscle mass using ultrasound which plays a role in critical care [13]. Studies have been done to establish relationship between mortality and muscle mass measured by ultrasound independently of illness severity [12]. The forementioned study used rectus femoris (RF) and vastus intermedius muscle mass measured at bedside [12]. The use of ultrasound is operator dependent and comes with a disadvantage of interobserver errors. An Indian study has been done to assess the intra and interobserver errors of arm muscle thickness measured by ultrasound in critical care [14]. This study was based on high ICC (Intraclass Correlation Co Efficient Factor) for both intra- and inter-observer measurement of flexor muscle thickness of the arm. The results imply that USG may be used as an objective and reliable tool for the assessment of thickness of flexor muscle of the arm by critical care physicians. Hence, we decided to use upper arm muscle which is also the most accessible muscle mass as a standard measurement in the study[13].

 

 
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