Efficacy of fenoldopam mesilate in controlling splanchnic ischemia during cardiopulmonary bypass - Fenoldopam and CPB
- Conditions
- Patients to be submitted to cardiac surgery with expected prolonged CPB timeMedDRA version: 9.1Level: LLTClassification code 10048935Term: Open heart surgery
- Registration Number
- EUCTR2008-000818-78-IT
- Lead Sponsor
- POLICLINICO SAN DONATO IRCSS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Complex cardiac surgery (aorto-coronaric bypass + valve surgery; ascendig aorta surgery; surgery of congenital cardiopathies in adults)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients less than 18 years of age
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: diuresis during CPB; levels of plasma lactates during the first postoperative 24 hours; postoperative serum creatinine peak;Primary end point(s): To decrease the onset of lactic acidosis;Main Objective: Aim of the study is to evaluate whether the use of fenoldopam during CPB is able to decrease the onset of lactic acidosis in patients at high risk of developing such condition
- Secondary Outcome Measures
Name Time Method