| CTRI Number |
CTRI/2024/12/078320 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
To study the relevance of using preoperative Controlling Nutritional Status Score in children undergoing congenital cardiac surgery to predict postoperative outcome. |
|
Scientific Title of Study
|
Predictive relevance of preoperative Controlling Nutritional Status Score in children undergoing congenital cardiac surgery |
| 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 |
UN Mehta Institute of Cardiology and Research Centre. |
| Address |
Room no 803, Department of Cardiac Anaesthesia, UN Mehta Institute of Cardiology and Research Centre,8th floor, A Block,Ahmadabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawana Sharma |
| Designation |
Resident |
| Affiliation |
UN Mehta Institute of Cardiology and Research Centre. |
| Address |
Room no 803,Department of Cardiac Anaesthesia, UN Mehta Institute of Cardiology and Research Centre,8the floor, A Block, Ahmadabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
7407533830 |
| Fax |
|
| Email |
bhawray13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venuthurupalli S P Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
UN Mehta Institute of Cardiology and Research Centre. |
| Address |
Room no 803, Department of Cardiac Anaesthesia, UN Mehta Institute of Cardiology and Research Centre,8th floor, A Block, Ahmadabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 803, Department of Cardiac Anaesthesia, UN Mehta Institute of Cardiology and Research Centre, Ahmadabad, Gujarat, India, 380016. |
|
|
Primary Sponsor
|
| Name |
DR VENUTHURUPALLI S P RAJESH |
| Address |
ROOM NO 803,DEPT OF CARDIAC ANAESTHESIA, U N MEHTA INSTITUTE OF CARDIOLOGY AND RESEARCH CENTRE, 8TH FLOOR, A BLOCK, , 380016 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| UN MEHTA INSTITUTE OF CARDIOLOGY AND RESEARCH CENTRE |
ROOM NO 803,DEPT OF CARDIAC ANAESTHESIA, U N MEHTA INSTITUTE OF CARDIOLOGY AND RESEARCH CENTRE,8TH FLOOR, A BLOCK, AHMEDABAD, 380016 |
|
|
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 |
UN Mehta Institute of Cardiology and Research Centre. |
Room no 803, Department of Cardiac Anaesthesia, UN Mehta Institute of Cardiology and Research Centre,8th floor, A Block.
Ahmadabad
GUJARAT |
7799026386
rajeshvsp.88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE UN MEHTA INSTITUTE OF CARDIOLOGY AND RESEARCH CENTRE. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Cardiac Surgery under Cardiopulmonary Bypass. |
|
| ExclusionCriteria |
| Details |
Patients aged less than 6 months, Patients aged more than 18 years, Preterm patients, Patients with preoperative sepsis, Patients requiring preoperative Mechanical Ventilation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We hypothesise that the scores at hospital presentation can predict in hospital prognosis of the patient with congenital cardiac disease independently of other known prognostic factor. |
At hospital presentation, Postoperative day 1, Postoperative day 2, day of extubation, day of shifting to ward from the ICU. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relation of CONUT to sepsis & prolonged hospital stay. |
Day of presentation to the hospital, day of surgery, postoperative day 1, postoperative day 2, day of extubation, day of shifting from the ICU to the ward. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/12/2024 |
| 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 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
|
- Despite recent advances in congenital cardiac surgery, there remain unmet need to reduce the high mortality rate and to assess the mortality risk in post operativeperiod. Recently, there was a line of evidences that nutritional status has a link to the prognosis of patients. Malnutrition is related to altered intestinal function, which could be due to hemodynamic changes. Intestinal congestion leads to bowel edema and overgrowth of bacteria flora, resulting in malabsorption, chronic inflammation, and malnutrition. The Controlling Nutritional Status (CONUT) score is a screening tool to identify undernourished patients in the hospitalized population. The score is derived from the values of serum albumin, total cholesterol and lymphocyte counts. Albumin represents the protein reserves; total cholesterol represents caloric depletion; and lymphocyte count represents immune defense. The decrease in each component was assigned with high score. Thus, the higher score means the worse nutritional status.
|