Comparison of Milrinone and Epinephrine on TAPSE

NCT ID: NCT07144267

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-03-30

Brief Summary

Cardiopulmonary bypass (CPB) is a critical technology in cardiac surgery, allowing for the temporary replacement of the heart and lung functions during intricate surgical procedures. it has significant post-surgical complications, the most important complications of CPB is right ventricle (RV) dysfunction. Diagnosis and management of RV dysfunction is crucial for maintenance of hemodynamic stability and organ function in early post-operation period and prognostic for later phase.

Detailed Description

Epinephrine is the most potent adrenergic agonist which has positive inotropic and chronotropic effects and enhanced conduction in the heart (β1), smooth muscle relaxation in the vasculature and bronchial tree (β2), and vasoconstriction (α1). Low doses of this agent (<0.1-0.2 μg/kg/min) mainly activate the β adrenoceptors with inotropic effects. Higher doses result in vasoconstrictor effect which takes the lead. Other effects include bronchial dilation, mydriasis, glycogenolysis, tachyarrhythmia, myocardial ischemia, pulmonary hypertension, hyperglycemia, and lactic acidosis. Epinephrine also reduces splanchnic and hepatic perfusion and increases metabolic workload of the liver. So this hypermetabolism that impairs oxygen exchange, glycolysis, and suppression of insulin cause lactic acidosis.

Milrinone is a phosphodiesterase-III inhibitor. This effect decreases the degradation of cyclic adenosine monophosphate (cAMP), increases the cAMP levels in cells, and then increases activation of protein kinase A. Therefore, its cardiac effects are positive inotropy and improved diastolic relaxation. Milrinone also causes potent vasodilation, with reduction in preload, afterload and pulmonary vascular resistance. Considering its characteristics, milrinone might be a useful agent for cardiac surgery patients.

Conditions

Cardiac Anaesthesia; Cardiopulmonary Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Epinephrine group (group E)

The patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping

Group Type: ACTIVE_COMPARATOR

Epinephrine

Intervention Type: DRUG

Normal saline bolus over 10 min followed by Epinephrine intravenous infusion of 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping

Milrinone group (group M)

patients will recieve an initial bolus dose of of 50 µg/kg, followed by 0.40 -0.80 µg/kg/min 5-10 minutes before aortic unclamping

Group Type: ACTIVE_COMPARATOR

Milrinone Injection

Intervention Type: DRUG

Milrinone initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping

Interventions

Epinephrine

Normal saline bolus over 10 min followed by Epinephrine intravenous infusion of 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping

Intervention Type: DRUG

Milrinone Injection

Milrinone initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status II & III
• Age between 18 and 70 years
• Both Gender
• Body mass index less than 40 kg/m2
• Ejection fraction of >40%
• Tricuspid annular plane systolic excursion (TAPSE) < 1.7cm

Exclusion Criteria

• Patient refusal.
• Preoperative RV impairment
• Pulmonary hypertension (estimated pulmonary artery systolic pressure > 50 mmHg)
• Patients with any contraindications to Transesophageal echocardiography (TEE)
• Redo or Re-exploration surgery
• Patients with chronic kidney disease (serum creatinine > 1.5 mg/ dl)
• Patients with chronic liver disease (child pugh B and C)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

maha abou-zeid

Professor of Anesthesia , surgical Intensive care and pain management Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Maha A AboZeid, Assistant professor

Role: CONTACT

mahazed@yahoo.com

01019216192 ext. 02

Other Identifiers

Milrinone on TAPSE

Identifier Type: -

Identifier Source: org_study_id