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Comparison of Milrinone and Epinephrine on TAPSE

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07144267
Acronym
Milrinone
Enrollment
102
Registered
2025-08-27
Start date
2026-03-01
Completion date
2028-03-30
Last updated
2026-02-25

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

Conditions

Cardiac Anaesthesia, Cardiopulmonary Bypass

Keywords

Cardiopulmonary bypass (CPB) -Tricuspid annular plane systolic excursion (TAPSE)-, Epinephrine - Milrinone

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.

Interventions

DRUGEpinephrine

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

anesthesiologist who performed TEE measurements and who was responsible for data collection will be blinded to patient group allocation

Intervention model description

Epinephrine group (group E): the patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping. Milrinone group (group M): the patients receive initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The incidence of change in Tricuspid annular plane systolic excursion (TAPSE) within 5 minutes post-cardiopulmonary Bypass from the basal valueBasal then within 5 mins post-cardiopulmonary bypassmeasured by Transesophageal echocardiography (TEE)

Secondary

MeasureTime frameDescription
Tricuspid annular plane systolic excursion (TAPSE)within 30-60 minutes post-cardiopulmonary bypassmeasured by Transesophageal echocardiography (TEE)
Incidence of Right Ventricular Dysfunction after Cardiac Surgery24 hours postoperativedetected by ECHO when Tricuspid annular plane systolic excursion (TAPSE) ≤1.7 cm
Incidence of Arrhythmiasintraoperatively and 24 hours postoperativeoccurrence of any Arrhythmia
Vasoactive-Inotrope Score (VIS)recorded at 6, 12, 24, and 48 hours postoperativeVasoactive-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
Total consumption doses of Vasopressors48 hours postoperativecumulative dose of any needed Vasopressors (Norepinepherine)

Contacts

CONTACTMaha A AboZeid, Assistant professor
mahazed@yahoo.com01019216192

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026