| CTRI Number |
CTRI/2024/06/068835 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Nutric score assesment in intubated patients |
|
Scientific Title of Study
|
Nutric score assesment in mechanically ventilated 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 |
Uvashree A |
| Designation |
Postgraduate student |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Deparment Of Critical Care Medicine
M.SC Critical Care Technology
Sri Ramachandra Institute Of Higher Education And Research
Porur
Chennai 600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
7397267957 |
| Fax |
|
| Email |
uvitara06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baby Sailaja K |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Registration |
| Address |
Associate Professor
Deparment Of Critical Care Medicine
Sri Ramachandra Institute Of Higher Education And Research
Porur
Chennai 600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9600153482 |
| Fax |
|
| Email |
babysailaja.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr MK Renuka |
| Designation |
Professor and Head Of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Registration |
| Address |
Department Of Critical Care Medicine
Sri Ramachandra Institute Of Higher Education And Research
Porur
Chennai 600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research
porur
Chennai 600116
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department of critical care medicine
M.SC Critical care technology
Sri Ramachandra Institute Of Higher Education And Research
Porur
Chennai 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Baby Sailaja k |
Sri Ramachandra Institute of higher education and research |
Department of critical care medicine
Porur
Chennai 600116
Thiruvallur
TAMIL NADU |
9600159482
babysailaja.k@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All mechanically ventilated patients at 48 hours period of time. |
|
| ExclusionCriteria |
| Details |
Any non-mechanically ventilated patients admitted to ICU.
Readmission of patients and patients transferred to outside hospital.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assesment of Nutric score in ventilated patients after 48 hours |
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality of patients secondary to malnourishment |
six months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/07/2024 |
| 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="0"
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
|
Nutritional support is an essential component of patient care in critically ill patients. Nutritional assessment is the cornerstone in identifying patients at risk of malnutrition and it has to be done within 48 h of hospital admission. Nutritional screening in ICU patients is challenging because many of the parameters such as accurate history of dietary intake and weight loss may be difficult to obtain, as most of the patients are on mechanical ventilation and sedation. Heyland et al. introduced the Nutrition Risk in Critically ill (NUTRIC) score, which identifies patients who will be benefited from aggressive nutrition by linking starvation, inflammation, and outcomes. Nutritional assessment in mechanically ventilated (MV) patients is a difficult task; the reasons being communication barrier in obtaining dietary history. Data on nutritional assessment in mechanically ventilated patients using NUTRIC score are limited. This study was conducted to identify the prevalence of nutritional risk in mechanical ventilation(MV) ICU patients with modified NUTRIC score |