PRIMACOR SUMMARY
PRIMACOR, brand of milrinone lactate injection, is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines.
PRIMACOR is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving PRIMACOR should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous PRIMACOR has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of PRIMACOR for periods exceeding 48 hours.
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NEWS HIGHLIGHTS
Published Studies Related to Primacor (Milrinone)
Low central venous pressure with milrinone during living donor hepatectomy. [2010.04]
Maintaining a low central venous pressure (CVP) has been frequently used in liver resections to reduce blood loss. However, decreased preload carries potential risks such as hemodynamic instability... Milrinone-induced low CVP improves the surgical field with less blood loss during living donor hepatectomy and also has favorable effects on intraoperative hemodynamics and postoperative recovery.
Effect of milrinone on short-term outcome of patients with myocardial dysfunction undergoing coronary artery bypass graft: A randomized controlled trial. [2010]
BACKGROUND: Myocardial dysfunction needing inotropic support is a typical complication after on-pump cardiac surgery. In this study, we evaluate the effect of milrinone on patients with ventricular dysfunction undergoing coronary artery bypass graft (CABG)... CONCLUSIONS: We suggest that perioperative administration of milrinone in patients undergoing on-pump CABG, especially those with low LVEF, is beneficial.
Randomized trial of milrinone versus placebo for prevention of low systemic blood flow in very preterm infants. [2009.02]
OBJECTIVE: To assess the effectiveness of early prophylactic milrinone versus placebo for prevention of low systemic blood flow in high-risk preterm infants... CONCLUSIONS: Milrinone did not prevent low systemic blood flow during the first 24 hours in very preterm infants, and no adverse effects were attributable to milrinone. Use of a preventative treatment with rescue model allowed comparison of an inotrope with placebo in this high-risk group of infants.
Milrinone use is associated with postoperative atrial fibrillation after cardiac surgery. [2008.10.14]
CONCLUSIONS: Milrinone use is an independent risk factor for postoperative AF after elective cardiac surgery.
Randomized Trial of Milrinone Versus Placebo for Prevention of Low Systemic Blood Flow in Very Preterm Infants. [2008.09.24]
OBJECTIVE: To assess the effectiveness of early prophylactic milrinone versus placebo for prevention of low systemic blood flow in high-risk preterm infants... CONCLUSIONS: Milrinone did not prevent low systemic blood flow during the first 24 hours in very preterm infants, and no adverse effects were attributable to milrinone. Use of a preventative treatment with rescue model allowed comparison of an inotrope with placebo in this high-risk group of infants.
Clinical Trials Related to Primacor (Milrinone)
Nebulized Inhaled Milrinone in a Hospitalized Advanced Heart Failure Population Awaiting Cardiac Transplantation [Suspended]
Patients with end stage heart failure have significant symptoms (including fatigue and
shortness of breath) which prevent them from being able to perform most activities of daily
living. Milrinone is one of the inotropic medications that has been studied and used in the
treatment of end stage heart failure. End stage heart failure patients awaiting a heart
transplantation often have to be maintained on IV milrinone 24 hours a day through a chronic
IV line. Two problems arise with this therapy. First, the IV line itself creates an
opportunity for infection and blood clots, in addition to interfering with patient's quality
of life. Second, patients may be exposed to higher levels of milrinone when given IV than
are necessary for maintaining their heart's function.
The investigators goal is to show that inhaled milrinone is equivalent to "standard of care"
IV milrinone in improving heart and lung pressures in end stage heart failure patients (who
respond to milrinone therapy) in a prospective, randomized, controlled clinical trial.
Patients who are sent for a right heart catheterization procedure by their cardiologist to
determine if they require milrinone while awaiting heart transplantation will be randomly
chosen to be in the continuous IV milrinone group or the inhaled milrinone group after
agreeing to participate in this study. Patients in the inhaled milrinone group will receive
6mg in 6ml of fluid inhaled by a vibrating mesh nebulizer every 4 hours. Patients in the IV
arm will receive a constant IV infusion rate. Both groups will have a repeat right heart
catheterization procedure an average of 48 hours after milrinone initiation to evaluate
their response to milrinone. Afterward, all patients that respond will be placed on the
standard of care IV milrinone for the duration of their therapy, as directed by their
cardiologist.
Effect of Brief Nebulization of Milrinone on Pulmonary Arterial Pressure Before Cardiopulmonary Bypass on Mitral Valve Surgery Patients [Completed]
Our main hypothesis is that inhalation of milrinone can reduce the elevated pulmonary
arterial pressure due to severe mitral valve regurgitation without compromising systemic
hemodynamics. Therefore, the effects of a brief inhaled milrinone (IH) on pulmonary artery
pressure are determined and compared to those of intravenous milrinone (IV) in severe mitral
regurgitation patients undergoing mitral valve surgery.
Inhaled Milrinone in Cardiac Surgery [Completed]
The purpose of this study is to investigate the concentration-effect relationship of inhaled
milrinone after prophylactic administration in cardiac surgical patients with preoperative
pulmonary hypertension undergoing cardiopulmonary bypass.
Milrinone Inhaled in Cardiac Surgery [Completed]
Pulmonary hypertension is an important morbidity factor in patients having to undergo
cardiac surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows
evidence of being a pulmonary vasodilator able to possibly contribute to the reduction of
pressure on the pulmonary artery.
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery [Terminated]
The staged surgical pathway to treat children with single ventricle heart defects culminates
with the Fontan operation. In this procedure, systemic venous return is rerouted directly to
the pulmonary arteries, which serves to separate the systemic and pulmonary circulations.
Although mortality following the Fontan operation is now uncommon, early postoperative
morbidity including prolonged postoperative chest tube drainage and hospitalization remains
significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory
therapies in the perioperative period is unknown and practice varies widely between centers.
The investigators will propose a single-center, randomized, double-blind, phase II clinical
trial in children undergoing Fontan surgery. The investigators plan to compare the effects
of perioperative nesiritide, milrinone and placebo infusions on the early postoperative
clinical course and neurohumoral profile. The investigators hypothesize that, when compared
to the milrinone and placebo groups, the nesiritide group will have more days alive and out
of the hospital within the first 30 days after surgery.
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