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Evaluation of the effects of levosimendan and Milrinone on the heart�s pumping effect in patients with impaired heart dysfunction undergoing coronary artery bypass surgery on bypass machine

A RCT ON COMPARATIVE EVALUATION OF THE HEMODYNAMIC EFFECTS OF LEVOSIMENDAN VS MILRINONE IN PATIENTS WITH MODERATE LV DYSFUNCTION UNDERGOING CORONARY ARTERY BYPASS GRAFTING ON CARDIOPULMONARY BYPASS [CPB]

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035202
Enrollment
24
Registered
2021-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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 Health Condition 2: I978- Other intraoperative and postprocedural complications and disorders of the circulatory system, not elsewhere classified

Interventions

Intervention1: milrinone and levosimendan: Twenty four patients will be allocated randomly into two groups to receive either milrinone, 50 �µg/kg bolus intra operatively followed by infusion at a ra

Sponsors

cmc Vellore fluid research grand
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients, between 40 and 70 years 2. Both sexes 3. Impaired left ventricular function (Ejection fraction � 40%), 4. Mean pulmonary artery pressure between 25-35 mmHg, 5. New York Heart Association (NYHA III & IV) 6. Undergoing elective On-Pump Coronary Artery Bypass Graft surgery

Exclusion criteria

Exclusion criteria: 1. Geriatric patients (age over 70 years). 2. Patients with end-organ failure (renal, liver). 3. Perioperative surgical complications unrelated to the study (accidental surgical trauma to a nearby organ or massive blood loss defined as blood loss exceeding circulating blood volume within a 24-hour period due to surgical insult). 4. Associated mitral or aortic valve disease. 5. Preoperative requirement of inotropes or mechanical ventilation.

Design outcomes

Primary

MeasureTime frame
a) Comparison of pre-operative and post-operative CO, CI, SVR.Timepoint: Pre operative, intra operative and post operative

Secondary

MeasureTime frame
a) Need for additional mechanical or pharmacological support. b) Duration to Wean off from mechanical ventilator support. c) Dosage and duration of inotropic supports. d) Requirement of additional drugs (dosage and duration) to combat the adverse effects e) Duration of ICU stay. f) Vasoactive-inotropic score for predicting surgical outcome.Timepoint: one week

Countries

India

Contacts

Public ContactMeenu Anna John

CMC Vellore

drsathish78@yahoo.com6369379259

Outcome results

None listed

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