Ischemia-reperfusion Injury. Clinical Trial
Official title:
The Safety of Vardenafil in Patients Undergoing Cardiac Surgery
| Verified date | November 2011 |
| Source | McGuire Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to evaluate the safety of vardenafil in cardiac surgery patients.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - undergoing cardiac surgery Exclusion Criteria: - emergent surgery - recent MI in past 7 days prior to surgery - ejection fraction < 35% - creatinine > 2.0 - prior CVA - severe COPD - recent use of nitrates (within past 48 hours prior to surgery) - prior CABG - pregnancy |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | McGuire VAMC | Richmond | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| McGuire Research Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hypotension | approximately 5 days | Yes | |
| Secondary | Ejection Fraction | approximately 5-7 days postop | No |