| CTRI Number |
CTRI/2026/02/104948 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between one dose or more than one dose of heart protection solution during heart bypass surgery helps patients recover better. |
|
Scientific Title of Study
|
Comparison Between Single Dose And Intermittent Dose Of Del Nido Cardioplegia Delivery Through Vein Grafts On Post Operative Outcomes In Patients Undergoing On-Pump Coronary Artery Bypass 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 |
Arsa Chettri |
| Designation |
MSc Perfusion Technology Student |
| Affiliation |
Manipal College of Health Professions-MCHP |
| Address |
Room no: 413, 4th Floor, Perfusion Technology Program, Manipal College of Health
Professions, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7628850949 |
| Fax |
|
| Email |
chettriarsa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Glory Mini Mol |
| Designation |
Assistant Professor-Perfusion Technology Program MCHP |
| Affiliation |
Manipal College of Health Professions-MCHP |
| Address |
Room no: 413, 4th Floor, Perfusion Technology Program, Manipal College of Health
Professions, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7397590555 |
| Fax |
|
| Email |
glory.a@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Glory Mini Mol |
| Designation |
Assistant Professor-Perfusion Technology Program MCHP |
| Affiliation |
Manipal College of Health Professions-MCHP |
| Address |
Room no: 413, 4th Floor, Perfusion Technology Program, Manipal College of Health
Professions, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7397590555 |
| Fax |
|
| Email |
glory.a@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Cardiovascular and Thoracic Surgery, Room No. 32, 3rd floor OPD building, Kasturba Medical College, Manipal, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Department of Cardiovascular and Thoracic Surgery |
| Address |
Room No. 32, 3rd floor OPD building, Kasturba Medical College, Manipal, Karnataka-576104 |
| 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 Guru Prasad Rai |
Kasturba Hospital |
Department of Cardiovascular and Thoracic Surgery, Room No. 32, 3rd floor OPD building,
Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9429314718
guru.rai@manipal .edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, Manipal, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I25||Chronic ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing isolated CABG surgery. |
|
| ExclusionCriteria |
| Details |
Patient with Pre-Op Hemoglobin less than 8g/dl
Emergency cardiac surgeries
Prior history of cardiac surgeries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the post-operative complications, pacing requirements, no. of ICU stays, Potassium Level, Echo findings from POD 0 – POD 1. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
09/03/2026 |
| 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="2"
Months="0"
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
|
This study will help identify the most effective cardioplegia delivery method i.e comparison between single dose and intermittent dose of del-nido cardioplegia through vein
grafts on post-operative outcomes in patient undergoing on-pump coronary artery bypass surgery, leading to better myocardial preservation and improved post operative recovery. |