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)
Milrinone Inhaled in Cardiac Surgery [Recruiting]
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 [Recruiting]
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.
Pharmacokinetic Study of Milrinone in Babies With Persistent Pulmonary Hypertension of the Newborn [Recruiting]
The purpose of this pilot study is to determine a safe dose of milrinone to use in a larger
study of babies with persistent pulmonary hypertension of the newborn (PPHN).
Inhaled Milrinone Use in Patients Receiving HeartMate II LVAD: A Pilot Study [Recruiting]
Right ventricular (RV) failure occurs in an estimated 5-41% of cases involving left
ventricular assist device (LVAD) implantation and has been shown to adversely affect
peri-operative morbidity and mortality. Current therapies to improve RV dysfunction pre and
post-operatively are limited. Inhaled milrinone has been shown in several small human
studies to be safely tolerated and provide favorable effects on pulmonary hemodynamics.
Study Hypothesis: Delivery of inhaled milrinone, a phosphodiesterase III inhibitor, may
provide pulmonary artery vasodilation and therefore improved RV function in patients with
end stage heart failure receiving HeartMate II LVAD as a bridge to cardiac transplantation
or as destination therapy.
Specifically, we aim to:
- demonstrate safety of inhaled milrinone in this patient cohort
- demonstrate efficacy of inhaled milrinone in this patient cohort
Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants [Recruiting]
Pediatric patients, especially infants undergoing open heart surgery have a predictable fall
in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome
(LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay
in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is
routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer
improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary
blood flow through calcium sensitization of the myocardial contractile filaments and
opening of potassium channels without increasing oxygen consumption of the heart muscle
cells. As the myocardium of infants is more calcium dependent than in later life,
levosimendan should be of special benefit in this age group. The purpose of this study is to
investigate whether levosimendan is superior to milrinone in preventing LCOS in infants
after corrective open heart surgery.
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