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Sponsored by: |
Università Vita-Salute San Raffaele |
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Information provided by: | Università Vita-Salute San Raffaele |
ClinicalTrials.gov Identifier: | NCT00621790 |
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.
Condition | Intervention | Phase |
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Acute Renal Failure |
Drug: fenoldopam Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study. |
Estimated Enrollment: | 1000 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days
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Drug: fenoldopam
fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
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2: Placebo Comparator
Placebo (normosaline), continuous perfusion
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Drug: placebo
placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: giovanni landoni, MD | +39.347.2520801 | landoni.giovanni@hsr.it |
Contact: tiziana bove, MD | +39.02.26434524 | bove.tiziana@hsr.it |
Italy | |
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia | Recruiting |
Milano, Italy, 20132 | |
Sub-Investigator: giovanni marino, MD |
Study ID Numbers: | GO/URC/ER/mm 64/DG |
Study First Received: | February 12, 2008 |
Last Updated: | February 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00621790 |
Health Authority: | Italy: Ministry of Health |
fenoldopam acute renal failure renal replacement therapy mortality |
cardiac surgery cardiac anesthesia intensive care unit |
Renal Insufficiency Dopamine Urologic Diseases Fenoldopam |
Renal Insufficiency, Acute Kidney Diseases Kidney Failure, Acute Kidney Failure |
Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Dopamine Agents Cardiovascular Agents Dopamine Agonists Antihypertensive Agents Pharmacologic Actions |