Fenoldopam mesilate efficacy to control splancnic ischemia during cardiopulmonary bypass in pediatric patients

INTERVENTION: Trade Name: CORLOPAM Pharmaceutical Form: Solution for injection INN or Proposed INN: Fenoldopam Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: cardiac surgery with CPB ; MedDRA version: 9.1 Level: SOC Classification code 10042613 PRIMARY OUTCOME: Main Objective: plasmatic lactate titration to evaluate the improvement of splancnic perfusion during CPB by Fenoldopam Mesylate administration Primary end point(s): Lactate titration at CPB end. Positive result to Fenoldopam Mesylate administration has to be considered the lactate value <2 mMol/l; Secondary Objective: postoperative plasmatic lactate titration and diureris evaluation INCLUSION CRITERIA: elective cardiac surgery for congenital heart disease bypass time > 60 < 180 minutes weight less/equal 15 Kg Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range