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Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery (SiPaHCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Turin, Italy
Sponsor:
Information provided by (Responsible Party):
Daniela Pasero, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01481350
First received: November 25, 2011
Last updated: February 13, 2013
Last verified: February 2013

November 25, 2011
February 13, 2013
February 2012
May 2013   (final data collection date for primary outcome measure)
reduced mechanical ventilation [ Time Frame: seven days ] [ Designated as safety issue: No ]
The primary outcome is the reduction of time on mechanical ventilation
Same as current
Complete list of historical versions of study NCT01481350 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery
Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery

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.

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.

Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: sildenafil
The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.
Experimental: Sildenafil
All patient will be treat with a intravenous administration of the drug from the beginning of the intervention, for a maximum of 72 hours.
Intervention: Drug: sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
August 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients undergoing valvular heart surgery associated to post capillary pulmonary hypertension with a mean pulmonary arterial pressure (mPAP)>30mmHg or pulmonary vascular resistance (PVR)>3Wu.

Exclusion Criteria:

  • patients younger than 18 years old
  • ischemic cardiomyopathy
  • Ejection Fraction (EF)<30%
  • severe Chronic obstructive pulmonary disease (COPD) with oxygen and bronchodilators therapy
  • chronic pulmonary disease, chronic renal failure on dialysis
  • hepatic failure
  • patients with orotracheal intubation and already admitted to the ICU before the intervention
Both
18 Years and older
No
Contact: Daniela Pasero, MD +390116335511 daniela.pasero@unito.it
Contact: Francesca Ivaldi, MD +390116335511 franiv@tin.it
Italy
 
NCT01481350
0064280
No
Daniela Pasero, University of Turin, Italy
University of Turin, Italy
Not Provided
Study Chair: Mauro Rinaldi, MD San Giovanni Battista, Hospital University of Turin
University of Turin, Italy
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP