Comparison of Milrinone and Epinephrine on TAPSE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Epinephrine, Milrinone Injection.
- Who it may be relevant to
- Registry conditions: Cardiac Anaesthesia, Cardiopulmonary Bypass. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Milrinone Versus Epinephrine for Right Ventricular Dysfunction After Cardiac Surgery in Adults: A Randomized Double-Blinded Trial
Overview
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
- Drug 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 - 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
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Tricuspid annular plane systolic excursion (TAPSE) [Time frame: within 30-60 minutes post-cardiopulmonary bypass]
- Incidence of Right Ventricular Dysfunction after Cardiac Surgery [Time frame: 24 hours postoperative]
- Incidence of Arrhythmias [Time frame: intraoperatively and 24 hours postoperative]
- Vasoactive-Inotrope Score (VIS) [Time frame: recorded at 6, 12, 24, and 48 hours postoperative]
- Total consumption doses of Vasopressors [Time frame: 48 hours postoperative]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07144267 · Milrinone on TAPSE