Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07144267

Comparison of Milrinone and Epinephrine on TAPSE

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Epinephrine

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 Injection

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

Primary outcomes

  1. The incidence of change in Tricuspid annular plane systolic excursion (TAPSE) within 5 minutes post-cardiopulmonary Bypass from the basal value

    Time frame: Basal then within 5 mins post-cardiopulmonary bypass

    measured by Transesophageal echocardiography (TEE)

Secondary outcomes

  1. Tricuspid annular plane systolic excursion (TAPSE)

    Time frame: within 30-60 minutes post-cardiopulmonary bypass

    measured by Transesophageal echocardiography (TEE)

  2. Incidence of Right Ventricular Dysfunction after Cardiac Surgery

    Time frame: 24 hours postoperative

    detected by ECHO when Tricuspid annular plane systolic excursion (TAPSE) ≤1.7 cm

  3. Incidence of Arrhythmias

    Time frame: intraoperatively and 24 hours postoperative

    occurrence of any Arrhythmia

  4. Vasoactive-Inotrope Score (VIS)

    Time frame: recorded at 6, 12, 24, and 48 hours postoperative

    Vasoactive-Inotrope Score = Dopamine (µg/kg/min) + Dobutamine (µg/kg/min) +100 x Epinephrine (µg/kg/min) +100 x Norepinephrine (µg/kg/min) + 10 x Milrinone (µg/kg/min) + 10,000 x Vasopressin

  5. Total consumption doses of Vasopressors

    Time frame: 48 hours postoperative

    cumulative dose of any needed Vasopressors (Norepinepherine)

Study contacts

Contact information is provided by the study sponsor or research team.

Maha A AboZeid, Assistant professor

CONTACT

[email protected]

01019216192 ext. 02

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Milrinone Versus Epinephrine for Right Ventricular Dysfunction After Cardiac Surgery in Adults: A Randomized Double-Blinded Trial

Acronym: Milrinone

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 27, 2025
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.