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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 time
MedDRA 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
NameTimeMethod
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
NameTimeMethod
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