| CTRI Number |
CTRI/2024/12/078404 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate whether the drug levosimendan or milrinone has more impact on reducing left atrial pressure in patients undergoing off pump coronary artery bypass grafting |
|
Scientific Title of Study
|
A randomized comparative double blind study to evaluate the efficacy of levosimendan versus milrinone on reducing left atrial pressure in patients undergoing off pump coronary artery bypass grafting at SMS Medical College, Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashna Fathima |
| Designation |
Postgraduate Resident |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Anaesthesiology, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7025088599 |
| Fax |
|
| Email |
ashna.mia29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Anaesthesiology, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS MEDICAL COLLEGE, Jaipur, Rajasthan, India, Pincode 302004 |
|
|
Primary Sponsor
|
| Name |
Ashna Fathima |
| Address |
Postgraduate resident, Department of Anaesthesiology, SMS Medical College, Jaipur, Rajasthan, Pincode 302004 |
| 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 |
| Dr Ashna Fathima |
SMS Medical College, Jaipur |
CARDIOTHORACIC OPERATION THEATRE, SECOND FLOOR, BANGAD PARISHAR, SMS MEDICAL COLLEGE, JAIPUR
Jaipur
RAJASTHAN |
7025088599
ashna.mia29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levosimendan |
Levosimendan 12 mcg/kg over 10 minutes diluted in 50 ml dextrose 5% in infusion pump followed by infusion of 0.1µg/kg/min intraoperatively started after induction upto completion of surgery |
| Comparator Agent |
Milrinone |
Milrinone 50 mcg/kg in 50 ml dextrose 5% in infusion pump and will continue infusion of infusion 0.5µg/kg/min via infusion pump intraoperatively started after induction upto completion of surgery |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade equal to or greater than 3
Patients with triple vessel coronary disease with ejection fraction greater than or equal to 40 percent |
|
| ExclusionCriteria |
| Details |
Patients with mitral regurgitation
Patients who underwent conversion to on pump coronary artery bypass grafting
Patients with critical left main coronary artery disease
Patients undergoing redo surgery
Patients with atrial fibrillation
Patients with regional wall motion abnormalities
Patients with mitral annular disorders
Patients with preoperative use of Milrinone or Levosimendan or allergy to these drugs
Patients who are a part of any other research study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Mitral early diastolic inflow velocity (E),
Mean Early diastolic mitral annular velocity (e’)
|
T1 After sternotomy,
T2 During grafting of reverse saphenous venous graft in the proximal aorta,
T3 Grafting of left anterior descending artery,
T4 Grafting of obtuse marginal artery,
T5 Grafting of posterior descending artery,
T6 Before sternal closure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate, Systolic blood pressure, Diastolic blood pressure, Mean blood pressure |
baseline, postinduction 1 minute, after sternotomy, 30 minutes after induction, 6hrs after surgery, 12 hrs after surgery, 24 hrs after surgery |
Central venous pressure, Cardiac index, Stroke volume variation, Systemic vascular resistance index
|
baseline, postinduction 1 minute, after sternotomy, 30 minutes after induction |
| complication, side effect |
within 24 hrs of surgery |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="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 study is to assess the comparative efficacy of levosimendan vs milrinone in reducing left atrial pressure in patients undergoing off pump coronary artery bypass grafting in SMS medical college Jaipur. The institutional ethics committee approval was obtained in october 2024.
|