patients undergoing heart surgery developing, in any moment during post surgery hospitalization in Intensive Care Unit, renal problems named as "R" of RIFLE score MedDRA version: 9.1 Level: SOC Classification code 10038359 Term: Renal and urinary disorders
Conditions
Interventions
Trade Name: CORLOPAM
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fenoldopam
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical f
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients undergoing heart surgery developing, in any moment during post surgery hospitalization in Intensive Care Unit, renal problems named as "R" of RIFLE score 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: glaucoma,discharge from Intensive Care Unit within 24 hours,renal substitutive treatment,possible exitus,inclusion in other studies,age under 18,lack of informed consent,patients treated with fenoldopam in prevoius month,pre surgery dialisis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate if Fenoldopam use versus placebo may improve the renal outcome in patients undergoing heart surgery;Secondary Objective: to evaluate if Fenoldopam use versus placebo may improve the renal outcome in patients undergoing heart surgery;Primary end point(s): prevention of placement of renal substitutive treatment | — |
Countries
Italy
Outcome results
None listed