Prophylaxis with fenoldopam in cardiac surgery patients at high risk of postoperative renal failure - ND

• Conditions: cardiac surgery patients at high risk of postoperative renal failure; MedDRA version: 9.1Level: HLGTClassification code 10007593Term: Cardiac therapeutic procedures

• Registration Number: EUCTR2006-003053-24-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

cardiac surgery requiring cardiopulmonary bypass in patients - high risk of postoperative renal failure - informed consent
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

-preoperative dialysis, - glaucoma, - allergy to fenoldopam

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of fenoldopam in postoperative renal failure prophylaxis in cardiac surgery;Secondary Objective: to decrease the incidence of postoperative oliguric renal failure and dialysis-dependent renal failure, the duration of postoperative intensive care unit and hospital stay;Primary end point(s): to decrease the incidence of postoperative renal failure, defined as an increase of baseline creatinine 50