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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003053-24-IT
Enrollment
160
Registered
2006-12-14
Start date
2006-05-18
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac surgery patients at high risk of postoperative renal failure MedDRA version: 9.1 Level: HLGT Classification code 10007593 Term: Cardiac therapeutic procedures

Interventions

Trade Name: CORLOPAM*20MG/2ML IV 1F 2ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Fenoldopam CAS Number: 67227-57-0 Concentration unit: µg microgram(s) Concentration type: equal

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: -preoperative dialysis, - glaucoma, - allergy to fenoldopam

Design outcomes

Primary

MeasureTime frame
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

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026