NCT00621790
Completed
Phase 3
Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.
Overview
- Phase
- Phase 3
- Intervention
- fenoldopam
- Conditions
- Acute Renal Failure
- Sponsor
- Università Vita-Salute San Raffaele
- Enrollment
- 667
- Locations
- 19
- Primary Endpoint
- Number of patients requiring Renal Replacement Therapy
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy.
Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.
Investigators
Giovanni Landoni
Head of Research, Anesthesia and Intensive Care Department
Università Vita-Salute San Raffaele
Eligibility Criteria
Inclusion Criteria
- •adult patients
- •who underwent cardiac surgery
- •have Risk of Acute Renal Failure (R of RIFLE score)
Exclusion Criteria
- •already on renal replacement therapy
- •study drug in the past 30 days
- •inclusion in other protocols
Arms & Interventions
Fenoldopam
Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days
Intervention: fenoldopam
Placebo
Placebo (normosaline), continuous perfusion
Intervention: placebo
Outcomes
Primary Outcomes
Number of patients requiring Renal Replacement Therapy
Time Frame: participants will be followed for the duration of intensive care unit stay, an expected average of one week
Secondary Outcomes
- Number of dead patients.(Participants will be followed for 1 year.)
Study Sites (19)
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