| CTRI Number |
CTRI/2025/04/084119 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [nutrition] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of assessing nutrition and supplementation of nutrition in ICU patients |
|
Scientific Title of Study
|
Effect over 15 days morbidity using local protocol of nutritional assessment and rehabilitation among patients in Anaesthesiology ICU |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Kumar |
| Designation |
Associate Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
117/H-2/184, PANDU NAGAR
Kanpur Nagar
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Kumar |
| Designation |
Associate Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
117/H-2/184, PANDU NAGAR
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Kumar |
| Designation |
Associate Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
117/H-2/184, PANDU NAGAR
UTTAR PRADESH
208005
India |
| Phone |
08874311115 |
| Fax |
|
| Email |
dr.nehamishra86@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM Medical College, Kanpur, Uttar Pradesh. 208002 |
|
|
Primary Sponsor
|
| Name |
GSVM Medical college |
| Address |
Department of Anaesthesia
GSVM Medical College
kanpur, Uttar Pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| NEHA MISHRA |
GSVM MEDICAL COLLEGE |
Department of Anaesthesia
GSVM Medical College
Kanpur
Kanpur Nagar
UTTAR PRADESH |
08874311115
dr.nehamishra86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSVM MEDICAL COLLEGE, KANPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
giving carbohydrate, protein, fat |
giving nutrition by calculating resting energy expenditure |
| Intervention |
giving carbohydrates, protein, fat |
assessment of nutrition and giving nutrition by standard methods |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients requiring ICU admissions with in 24 hours
patient on ventilator for more than 72 h
patient not taking oral feeds |
|
| ExclusionCriteria |
| Details |
patient not requiring ventilation for more than 72 hrs
patient discharged with in 7 days |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sample size , efficacy of nutritional supplementation in terms of anthropometric parameters, biochemical parameters and clinical parameters. |
baseline, one week and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| safety of nutritional supplementation, looking for adverse effects |
baseline, 1 week & 2 weeks |
|
|
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)
|
15/04/2025 |
| 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 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
|
To Assess nutrition in ICU Patients and supplement nutrition by standard method and by calculating Resting Energy Expenditure. |