Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery (SiPaHCS)
|ClinicalTrials.gov Identifier: NCT01481350|
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : December 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: sildenafil||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||December 2013|
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.
- reduced mechanical ventilation [ Time Frame: seven days ]The primary outcome is the reduction of time on mechanical ventilation
- ICU length of stay [ Time Frame: 28 days ]The secondary outcome is to evaluate the reduction of intensive care unit length of stay.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481350
|San Giovanni Battista Hospital University of Turin|
|Turin, Italy, 10126|
|Study Chair:||Mauro Rinaldi, MD||San Giovanni Battista, Hospital University of Turin|