| CTRI Number |
CTRI/2023/02/049956 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
20/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess how adding the body measurements along with modified NUTRIC score help in predicting the survical in patients admitted in the ICU of a hospital. |
|
Scientific Title of Study
|
To assess the complementarity of modified NUTRIC score and anthropometric measurements in predicting ICU outcomes in critically ill patients in a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PREM PRAKEERTH P |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ST. JOHNS MEDICAL COLLEGE, BENGALURU |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE
ST.JOHNS MEDICAL COLLEGE
BENGALURU
DEPARTMENT OF CRITICAL CARE MEDICINE,
ST.JOHNS MEDICAL COLLEGE,
BENGALURU
Bangalore
KARNATAKA
560034
India |
| Phone |
6238023550 |
| Fax |
|
| Email |
premprakeerth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BHUVANA KRISHNA |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
ST. JOHNS MEDICAL COLLEGE, BENGALURU |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE
ST.JOHNS MEDICAL COLLEGE
BENGALURU
ROOM 338, MERCY HOSTEL
ST JOHNS MEDICAL COLLEGE
BENGALURU
Bangalore
KARNATAKA
560034
India |
| Phone |
9945693221 |
| Fax |
|
| Email |
bhuvana.11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PREM PRAKEERTH P |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ST. JOHNS MEDICAL COLLEGE, BENGALURU |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE
ST.JOHNS MEDICAL COLLEGE
BENGALURU
DEPARTMENT OF CRITICAL CARE MEDICINE,
ST.JOHNS MEDICAL COLLEGE,
BENGALURU
Bangalore
KARNATAKA
560034
India |
| Phone |
6238023550 |
| Fax |
|
| Email |
premprakeerth@gmail.com |
|
|
Source of Monetary or Material Support
|
|
MICU FIRST FLOOR
DEPARTMENT OF CRITICAL CARE MEDICINE
ST.JOHNS MEDICAL COLLEGE HOSPITAL, BENGALURU
PIN CODE: 560034 |
|
|
Primary Sponsor
|
| Name |
NO SPONSOR |
| Address |
NIL |
| Type of Sponsor |
Other [NO SPONSOR] |
|
|
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 Prem PrakeerthP |
ST JOHNS MEDICAL COLLEGE HOSPITAL |
DEPARTMENT OF CRITICAL CARE MEDICINE
ST JOHNS MEDICAL COLLEGE
BANGALORE
Bangalore
KARNATAKA |
6238023550
premprakeerth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ST JOHNS MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: R948||Abnormal results of function studies of other organs and systems, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 yrs of age, and within 48 hours of admission to the ICU |
|
| ExclusionCriteria |
| Details |
Patients who remained in the ICU for less than 24 hrs.
Pregnant women.
Absent consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess if anthropometric measurements can complement mNUTRIC score at admission in predicting the length of ICU stay, duration of mechanical ventilation and 28 day mortality in critically ill patients admitted to the ICU. |
28 days after ICU admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the nutritional status of critically ill patients admitted to the ICU using both mNUTRIC score and anthropometric measurements. |
At the time of ICU admission |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/02/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Several scores have been used for assessing the
nutritional status in critically ill patients admitted to ICU.
Majority of these scores utilize weight/BMI as one of
the parameter to assess the nutritional status. In patients admitted to the
ICU, it is challenging to measure their exact weights, as it require dedicated
equipments/infrastructure, which may not
be possible always especially in resource limited settings.
mNUTRIC score which was developed for nutrition risk
assessment of critically ill patients,
does not include weight/BMI as a parameter. Also it neither include any of the
anthropometric measurements related to the patient which may be considered as a
drawback.
This study aims at including anthropometric
measurements (triceps skin fold thickness and mid upper arm circumference )
with mNUTRIC score, and assessing their complementarity in predicting outcome
in critically ill patients admitted to the ICU. |