Fenoldopam and renal insufficiency - ND

• Conditions: 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: 9.1Level: SOCClassification code 10038359Term: Renal and urinary disorders

• Registration Number: EUCTR2007-003045-33-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-02
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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