Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
Status:
Terminated
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
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.