Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Heart Defects, Congenital
In brief
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.
Key facts
- Study ID
- NCT00543309
- Run by
- John M Costello
- People needed
- 106
- Starts
- 2007-10-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2018-06-25
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing an elective, primary Fontan operation at Children's Hospital Boston.
You may not qualify if…
- Revision surgery for failing Fontan circulation.
- Preoperative serum creatinine > 1.5 mg/dL or chronic dialysis.
- The attending surgeon, cardiac anesthesiologist, or cardiac intensivist has a compelling indication to initiate either nesiritide or milrinone outside of the confines of the study.
Where it is running
- Children's Hospital Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.