Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery (SiPaHCS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|