| CTRI Number |
CTRI/2022/01/039698 [Registered on: 25/01/2022] Trial Registered Prospectively |
| Last Modified On: |
21/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An study to find out nutritional assessment, prescription, practices and its outcome among sick/ critically ill patients in a selected tertiary care hospital of Udupi District. |
|
Scientific Title of Study
|
An observational study of nutritional assessment, prescription, practices and its outcome among critically ill patients in a selected tertiary care hospital of Udupi District. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Teena Sharon |
| Designation |
Nurse practitioner student |
| Affiliation |
Manipal college of Nursing , Manipal |
| Address |
Manipal College of Nursing ,MAHE, Manipal
576104
Other |
| Phone |
9743578329 |
| Fax |
|
| Email |
teena.sharon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini G Nayak |
| Designation |
Assistant professor |
| Affiliation |
Manipal college of Nursing , Manipal |
| Address |
Manipal College of Nursing, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9481375675 |
| Fax |
|
| Email |
Shalini.mcon@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Shanbhag |
| Designation |
Assistant Professor |
| Affiliation |
KMC manipal |
| Address |
Department of Critical Care Medicine, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901960496 |
| Fax |
|
| Email |
vishal.shanbhag@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self funded,
Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Teena sharon |
| Address |
Manipal College of Nursing, MAHE , Manipal |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Teena sharon |
Kasturba Hospital, Manipal |
Multidisciplinary intensive care unit(ICU 1) , Intensive care unit(ICU 2) ,High dependency unit (ICU 3).
Udupi
KARNATAKA |
9743578329
teena.sharon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E640||Sequelae of protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients over 18 years of age admitted to ICU or transferred to ICU
2)On enteral feeding
3)willing to participate in the study as consent by patient and /Or patient party
4)eligible to conduct muscular ultrasound evaluation |
|
| ExclusionCriteria |
| Details |
1)Patient with lower limb amputation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be significant relationship between nutritional status and the clinical outcomes variables such as 28-days mortality, ICU length of stay in ICU(LOS), risk of pressure sores and number of hospital acquired infections. |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the effects related to inadequate nutrition |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/01/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An observational study of nutritional assessment, prescription, practices and its outcome among the critically ill patients in a selected tertiary care hospitals of Udupi District .The purpose of the study is to identify the patients having high nutritional risk and thereby intervene to improve the nutritional status in the critical care units. Study aims at observing the prescribed and practiced nutrition and its potential effects on the muscle mass (on day 1, day 7,and day 14) and prognostic performance/mortality at 28 days. The findings of the study may help to provide quality and patient centered care among ICU patients and reduce the effects related to inadequate nutrition. |