Patients to be submitted to cardiac surgery with expected prolonged CPB time MedDRA version: 9.1 Level: LLT Classification code 10048935 Term: Open heart surgery
Conditions
Interventions
Trade Name: CORLOPAM
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fenoldopam
Concentration unit: mg/kg/h milligram(s)/kilogram/hour
Concentration type: equal
Concentration number: .
Sponsors
POLICLINICO SAN DONATO IRCSS
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Patients less than 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed