| CTRI Number |
CTRI/2024/09/073770 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How common is less muscle mass in patient with end stage liver disease |
|
Scientific Title of Study
|
To study prevalence of Sarcopenia in a patients with decompensated liver cirrhosis in tertiary care hospital |
| 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 Virendra Bhad |
| Designation |
Senior resident |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of gastroenterology ,AVBRH campus , Sawangi Meghe , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8169434732 |
| Fax |
|
| Email |
virendrabhad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIJENDRA KIRNAKE |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of gastroenterology ,AVBRH campus , Sawangi Meghe , Wardha
Nagpur
MAHARASHTRA
440034
India |
| Phone |
07768901370 |
| Fax |
|
| Email |
drvijendrakirnake@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Virendra Bhad |
| Designation |
Senior resident |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of gastroenterology ,AVBRH campus , Sawangi Meghe , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8169434732 |
| Fax |
|
| Email |
virendrabhad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Virendra Bhad Senior resident , Department of Gastroenterology, C block Jawaharlal Nehru Medical college, Sawangi Meghe, Wardha, Maharashtra
422001 India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha Maharashtra 422001 India |
| Type of Sponsor |
Private 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 Virendra Bhad |
Jawaharlal Neharu Medical College |
C Block 1st Floor Department of Gastroenterology Acharya Vinoba Bhave rural hospital, Jawaharlal Nehru Medical College, Sawangi meghe wardha 442001 Wardha MAHARASHTRA
Wardha
MAHARASHTRA |
8169434732
virendrabhad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients visiting (OPD/IPD) in AVBRH having a diagnosis of cirrhosis of liver will be included in this study. The diagnosis of Sarcopenia in liver cirrhosis is by various definitions of sarcopenia . |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study prevalence of sarcopenia in a patients with cirrhosis of liver |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
N/A |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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)
|
19/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/09/2024 |
| 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 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
|
The study will be conducted only after a clearance is obtained from the local ethical committee of Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha by submitting a synopsis mentioning all the proposed study details and protocols. It is Observational Prospective Study The study will be conducted in Acharya Vinoba Bhave rural Hospital (AVBRH), a tertiary care teaching hospital situated in the rural area of Wardha District. The aforementioned hospital, AVBRH, is a 1500+ bedded teaching hospital providing healthcare to the rural people of central India. Detailed history and physical examination will be performed. Below tests are done for sarcopenia. CT scan will be done to look for skeletal muscle index at 3rd lumbar vertebrae. It is the only modality that has validated sex- specific cut-offs, notably <50 cm2/m2 in men and <39 cm2/m2 in women. Mid-arm muscle circumference (MAMC): MAMC (in cm) is obtained by measuring the mid-arm circumference (MAC; in cm) and tricep skinfold (TSF; in mm). These measures are cheap, quick and can be safely used in routine clinical practice to assess repeated measures of sarcopenia. Muscle strength :The most frequently used modality is hand grip strength (HGS) as it is simple and can be used for repeated measures. It is recommended by the recent European guidelines in the assessment of patients with cirrhosis. HGS has been shown to be a better predictor of adverse clinical outcomes than CT measures of muscle mass and model for end-stage liver disease (MELD). Muscle function :Short Physical Performance Battery (SPPB) consists of chair stands, gait speed and balance (each scored out of 4; with a maximal score of 12) and a score <10 increases the odds of mortality by 2.5 Liver Frailty Index (LFI):It replaces gait speed with HGS and is sub-categorised into frail (>4.4), pre-frail (3.2 - 4.4) and robust (<3.2). Aerobic exercise capacity:This relies on muscle function, and can be assessed using the easy-to-apply, objective 6-minute walk distance (6MWD) or the more expensive, time-consuming cardiopulmonary exercise test (CPET).A 6MWD of less than 250 m represents poor muscle function/exercise capacity and is associated with two-fold increased mortality in patients on the transplant waiting list.
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