| 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
|
|
|
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
|
|
|
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]. |