Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- reduced mechanical ventilation
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: sildenafil (Drug)
Outcomes
Primary Outcomes
reduced mechanical ventilation
Time Frame: seven days
The primary outcome is the reduction of time on mechanical ventilation
Secondary Outcomes
- ICU length of stay(28 days)
Investigators
Daniela Pasero
Medical Doctor
University of Turin, Italy