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

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078404

Enrollment

Registered

2024-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Interventions

Intervention1: 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 com

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade equal to or greater than 3 Patients with triple vessel coronary disease with ejection fraction greater than or equal to 40 percent

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Secondary

Measure	Time frame
Heart Rate, Systolic blood pressure, Diastolic blood pressure, Mean blood pressureTimepoint: 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 Timepoint: baseline, postinduction 1 minute, after sternotomy, 30 minutes after induction;complication, side effectTimepoint: within 24 hrs of surgery	—

Measure

Time frame

Heart Rate, Systolic blood pressure, Diastolic blood pressure, Mean blood pressureTimepoint: 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 Timepoint: baseline, postinduction 1 minute, after sternotomy, 30 minutes after induction;complication, side effectTimepoint: within 24 hrs of surgery

—

Primary

Measure	Time frame
Mean Mitral early diastolic inflow velocity (E), Mean Early diastolic mitral annular velocity (e’) Timepoint: 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	—

Countries

India

Contacts

Public ContactAnjum Saiyed

SMS Medical College, Jaipur

dranjumsaiyed@gmail.com9214021930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026