| CTRI Number |
CTRI/2024/09/074475 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Ensure patient safety by utilizing a mobile tool in scoring Modified NUTRIC and APACHE-II among adult intensive care unit patients |
|
Scientific Title of Study
|
An observational prospective study using digital scoring tools for severity of illness and nutritional risk in adult ICU 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 |
Surya S |
| Designation |
Post graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
7200474503 |
| Fax |
|
| Email |
suryaselvam1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M K Renuka |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| 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 |
|
Details of Contact Person
Public Query
|
| Name |
Dr M K Renuka |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| 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
|
| Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu - 600116, India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Critical Care Medicine, 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 MK Renuka |
Sri Ramachandra Institute of Higher Education and Research |
Department of Critical Care Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116
Thiruvallur
TAMIL NADU |
8056126336
renuka.mk@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted to adult intensive care unit.
Patient who remains in intensive care unit for minimum 48hours. |
|
| ExclusionCriteria |
| Details |
Patients below the age group of 20 years.
Patients who were admitted in intensive care unit for less than 48 hours. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ensure patient safety among ICU patients using modiied NUTRIC and APACHE II score |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the patient outcomes, predict mortality, length of stay in hospital |
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/10/2024 |
| 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
|
In the year 2016 Rahman et al did a study on “Identifying critically ill patients who will benefit most from nutritional therapy using NUTRIC score “This study validated the NUTRIC score in a large ICU population and confirmed that patients with higher NUTRIC scores, including high APACHE II scores had worse clinical outcomes.
Nutrition scores in a critical care unit are essential tools used to assess the nutritional status of critically ill patients. These scores help guide nutritional interventions and improve patient outcomes. Some commonly used nutrition scores in critical care include: or severely malnourished. In 2011, Heyland et al. presented a new screening tool called Nutrition Risk in Critically ill (NUTRIC) score, which was validated for ICU patients. This score evaluates adverse outcome risk (mortality) modifiable by intensive nutritional intervention.
This study was conducted to ensure patient safety with the help of modified NUTRIC and APACHE II score by predicting mortality, length of hospital stay and nutritional risk among adult intensive care unit patients. |