| CTRI Number |
CTRI/2024/08/072538 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study association of sequential organ failure assessment score with severity of muscle wasting in critically ill patients |
|
Scientific Title of Study
|
Prospective observational study for association of Sequential organ failure assessment score with severity of muscle wasting 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 |
Himanshu Jindal |
| Designation |
PG Anaesthesia |
| Affiliation |
Vardhman mahavir medical College and safdarjung hospital |
| Address |
Department of anaesthesia, Main OT building, Room no 1 division 1, Ground floor,vardhman mahavir medical College and safdarjung hospital, New Delhi
South
DELHI
110029
India |
| Phone |
8076658471 |
| Fax |
|
| Email |
jindalhimanshu31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate professor |
| Affiliation |
Vardhman Mahavir medical College and safdarjung hospital |
| Address |
Department of anaesthesia, Main OT building, Room no 1,division 1, Ground floor,Vardhman Mahavir medical College and safdarjung hospital
South
DELHI
110029
India |
| Phone |
9871372430 |
| Fax |
|
| Email |
Ajayk17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate professor |
| Affiliation |
Vardhman Mahavir medical College and safdarjung hospital |
| Address |
Department of anaesthesia, Main OT building, Room no 1,division 1, Ground floor,Vardhman Mahavir medical College and safdarjung hospital
South
DELHI
110029
India |
| Phone |
9871372430 |
| Fax |
|
| Email |
Ajayk17@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Himanshu jindal |
Vardhman mahavir medical College and safdarjung hospital, New Delhi-110029 |
New emergency building,anaesthesia ICU, room no. 1, division 1, 1st floor, department of anaesthesia, vardhman mahavir medical College and safdarjung hospital.
South
DELHI |
8076658471
jindalhimanshu31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of VMMC and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, (3) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill patients with an expected length of ICU stay of atleast 7 days. |
|
| ExclusionCriteria |
| Details |
Pregnancy, known neuromuscular disorder, corticosteroid therapy, amputated limbs, burns patients, and admitted to other ICU in last one month. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SOFA score calculation and rectus femoris muscle wasting assessment |
Daily for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of severity of rectus femoris muscle wasting and duration of ICU stay |
Daily from day 1 to day 7 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
15/09/2024 |
| 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)
Modification(s)
|
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
Modification(s)
|
This is a prospective observational study done in Anaesthesia ICU, new emergency building VMMC & SJH, to evaluate the association of SOFA score with USG guided severity of rectus femoris muscle wasting in critically ill patients with atleast 7 days ICU stay. The SOFA score and rectus femoris muscle wasting will be measured daily from day 1 to day 7 of icu stay. Association between rectus femoris muscle wasting and duration of ICU stay will also be evaluated from day 1 to day 7. |