| CTRI Number |
CTRI/2024/12/078080 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
effect of nutrition scores in robotic cardiac bypass |
|
Scientific Title of Study
|
The influence of preoperative nutritional scores on postoperative outcomes in robotic assisted coronary artery bypass grafting - A Retrospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venuthurupalli S P Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
B.J.Medical College |
| Address |
U N Mehta Institute of Cardiology and Research Centre Asarwa Ahmedabad 380016 Gujarat India
Haripura Asarwa Ahmedabad Gujarat 380016 India
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venuthurupalli S P Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
B.J.Medical College |
| Address |
Department of Cardiac Anaesthesia U N Mehta Institute of Cardiology and Research Centre Asarwa Ahmedabad 380016 Gujarat India
Haripura Asarwa Ahmedabad Gujarat 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venuthurupalli S P Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
B.J.Medical College |
| Address |
U N Mehta Institute of Cardiology and Research Centre Asarwa Ahmedabad 380016 Gujarat India
Haripura Asarwa Ahmedabad Gujarat 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
|
Source of Monetary or Material Support
|
| U N Mehta Institute of Cardiology and Research Center Civil Hospital Campus Asarwa Ahmedabad-380016 Gujarat India |
|
|
Primary Sponsor
|
| Name |
U N Mehta Institute of Cardiology and Research Centre |
| Address |
U N Mehta Institute of Cardiology and Research Centre Civil hospital campus asarwa ahmedabad gujarat 380016 |
| 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 Venuthurupalli S P Rajesh |
U N Mehta Institute of Cardiology and Research Centre |
Department of Cardiac Anaesthesia 7th floor OT complex U N Mehta Institute of Cardiology and Research Centre Civil hospital campus Asarwa Ahmedabad Gujarat 380016
Ahmadabad
GUJARAT |
7799026386
rajeshvsp.88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee UNMICRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I978||Other intraoperative and postprocedural complications and disorders of the circulatory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the patients who underwent Robotic CABG will be included.
Age must be 20-80 years |
|
| ExclusionCriteria |
| Details |
Patients with inadequate missing data will be excluded
Age more than 80 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Controlling Nutritional Status (CONUT) score, Prognostic Nutritional Index (PNI), and Geriatric Nutritional Risk Index (GNRI) to assess the scores with higher predictive value |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| length of icu stay & other outcomes |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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)
|
25/12/2024 |
| 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 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
|
•Adequate nutritional risk
assessment is crucial to identify patients at nutritional risk and/or with poor
nutritional status before surgery to allow tailored initiation of optimization
strategies.
•The
Controlling Nutritional Status (CONUT)
score, Prognostic Nutritional Index (PNI),
and Geriatric Nutritional Risk Index (GNRI)
are objective nutritional indices that can be assessed using simple and
available parameters: serum albumin level, serum total cholesterol level, total
lymphocyte count, and body weight.
•Aim is to assess the score with higher
predictive value .
•Early prediction of morbidity |