Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery (SiPaHCS)
Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac surgery for valvular heart diseases, especially in patients with a long life mitral valve disease. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery|
- reduced mechanical ventilation [ Time Frame: seven days ] [ Designated as safety issue: No ]The primary outcome is the reduction of time on mechanical ventilation
- ICU length of stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]The secondary outcome is to evaluate the reduction of intensive care unit length of stay.
|Study Start Date:||February 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
All patient will be treat with a intravenous administration of the drug from the beginning of the intervention, for a maximum of 72 hours.
The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.
Pulmonary hypertension represents an increased risk for perioperative patients undergoing cardiac surgery for valvular heart disease especially in patients with a long life mitral valve disease complicated by sever pulmonary hypertension, with high risk of developing post operative right ventricular failure during separation from cardiopulmonary by pass. A recent study showed that a single oral administration of sildenafil at the beginning of the cardiac intervention in patients undergoing valvular heart surgery complicated by pulmonary hypertension reduces pulmonary vascular resistances without inducing significant effects on systemic vascular resistances. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle avoiding right ventricular failure. This should support weaning from cardiopulmonary by pass in patients undergoing cardiac surgery for valvular heart diseases associated to pulmonary hypertension.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481350
|San Giovanni Battista Hospital University of Turin|
|Turin, Italy, 10126|
|Study Chair:||Mauro Rinaldi, MD||San Giovanni Battista, Hospital University of Turin|