| CTRI Number |
CTRI/2024/05/067495 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of nutrition on recovery after cardiac surgery |
|
Scientific Title of Study
|
The Predictive role of Geriatric Nutritional risk index on postoperative outcomes in cardiac surgical patients-A Prospective Observational 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 |
Sanjana S |
| Designation |
Cardiac anaesthesia Registrar |
| Affiliation |
The Madras medical mission |
| Address |
Institute of cardiovascular diseases,The Madras Medical Mission hospital,No 4,Dr JJ nagar,Chennai-600037
Chennai
TAMIL NADU
600037
India |
| Phone |
9176476473 |
| Fax |
|
| Email |
sanjmanju46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujatha DI |
| Designation |
Senior consultant,Cardiac anaesthesia |
| Affiliation |
The Madras Medical Mission hospital |
| Address |
Institute of cardiovascular diseases,The Madras Medical Mission Hospital,,4A,Dr JJ nagar,Mogappair,Chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
9444028687 |
| Fax |
|
| Email |
sujathaaravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujatha DI |
| Designation |
Senior consultant,Cardiac anaesthesia |
| Affiliation |
The Madras Medical Mission hospital |
| Address |
Institute of cardiovascular diseases,The Madras Medical Mission Hospital,,4A,Dr JJ nagar,Mogappair,Chennai
Chennai
TAMIL NADU
600037
India |
| Phone |
9444028687 |
| Fax |
|
| Email |
sujathaaravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of cardiovascular diseases,The Madras medical mission hospital,No 4,Dr JJ
nagar,Mogappair,Chennai-600037 |
|
|
Primary Sponsor
|
| Name |
SANJANAS |
| Address |
Institute of cardiovascular diseases,The Madras medical mission,No 4A,Dr JJ nagar,Mogappair,Chennai-600037 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DrSujatha |
The Madras Medical mission hospital |
1 st floor,Institute of cardiovascular diseases,No 4 A,Dr.JJ nagar,mogappair,chennai-600037
Chennai
TAMIL NADU |
9444028687
sujathaaravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,The Madras Medical Mission |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: I20-I25||Ischemic heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Elective cardiac surgery
2.Isolated CABG
3.Isolated valve surgery
4.CABG plus vaLVE SURGERY |
|
| ExclusionCriteria |
| Details |
1.History of AF
2.Emergency surgery
3.Terminal illness
4.Death during hospitalisation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of relationship between preoperative malnutrition as predicted by geriatric nutritional risk index(GNRI) on postoperative atrial fibrillation after cardiac surgery between no risk,low risk ,moderate risk and high risk groups
|
1.Postoperative day 1
2.30 days
3.60 days
3.90 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the 3 months outcome between the low, moderate, major risk groups and the no risk group namely duration of ICU stay, hospitalisation period , local Infection, bleeding, AKI, stroke, pneumonia, heart failure and 90 day all cause readmission and 90 day all cause mortality
|
1.Postoperative day 1
2.30 days
3.60 days
3.90 days |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
27/05/2024 |
| 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="1"
Months="0"
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
|
The preoperative nutritional status will be evaluated using GNRI within 48 hours of admission. GNRI was calculated using the following formula: GNRI = [1.489 * albumin (g/dL)] + [41.7 * body weight (kg)/ideal body weight (kg)].
According to previously described cutoffs for GNRI, the patients will be stratified into 4 groups according to malnutrition risk as: No-risk (GNRI > 98) , Low-risk (GNRI 92 to ≤ 98) Moderate risk (GNRI 82 to <92) High risk (GNRI < 82) GENERAL data such as age ,Sex,BMI,Smoking and comorbidities like Hypertension,Diabetesmellitus,Heart failure and COPD will be recorded. LVEF in % and type of surgical procedure will be documented.Then patient will be followed up for post op atrial fibrillation. POAF will be determined based on the documentation of 12-lead electrocardiogram, or Holter monitoring of atrial fibrillation (AF) episodes (duration ≥ 30 seconds) during hospitalization.The duration of ICU stay, hospitalisation period , local Infection, bleeding, AKI, stroke, pneumonia, heart failure will be recorded.The patients will be followed upfor 90 days through telephonic interview to document all cause readmission and all cause mortality.Comparison will be done between the low, moderate, major risk groups and the no risk group for the occurrence of post operative AF, duration of ICU stay, hospitalisation period , local Infection, bleeding, AKI, stroke, pneumonia, heart failure and 90 day all cause readmission and mortality |