Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
667 participants
INTERVENTIONAL
2008-02-29
2013-06-30
Brief Summary
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Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fenoldopam
Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days
fenoldopam
fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
Placebo
Placebo (normosaline), continuous perfusion
placebo
placebo
Interventions
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fenoldopam
fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Università Vita-Salute San Raffaele
OTHER
Responsible Party
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Giovanni Landoni
Head of Research, Anesthesia and Intensive Care Department
Locations
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A.O. Universitario Policlinico S.Orsola Malpighi
Bologna, , Italy
Pres.Ospedal. Spedali Civili Brescia - Brescia
Brescia, , Italy
Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro
Catanzaro, , Italy
Azienda Ospedaliero Universitaria Careggi - Firenze
Florence, , Italy
Città di Lecce Hospital GVM Care and Research Lecce
Lecce, , Italy
Villa Maria Cecilia di Cotignola
Lugo Di Ravenna, , Italy
Azienda Ospedaliera Papardo - Messina
Messina, , Italy
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Milan, , Italy
Azienda Ospedaliera Vincenzo Monaldi - Napoli
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Azienda Ospedaliera di Perugia - Policlinico Monteluce(Osp. S.Maria della Misericordia)
Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana - Pisa
Pisa, , Italy
A.O.Universitario Policlinico Tor Vergata - Roma
Roma, , Italy
Ospedale Civile SS Annunziata di Sassari
Sassari, , Italy
Azienda Ospedaliera Universitaria Senese (Policlinico S.Maria alle Scotte)
Siena, , Italy
Azienda Ospedaliera San Giovanni Battista Molinette di Torino
Torino, , Italy
Ospedale Mauriziano Umberto I di Torino
Torino, , Italy
Ospedale S.Maria di Ca' Foncello
Treviso, , Italy
Azienda Ospedaliera Universitaria Santa Maria della Misericordia
Udine, , Italy
Countries
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References
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Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.
Bove T, Zangrillo A, Guarracino F, Alvaro G, Persi B, Maglioni E, Galdieri N, Comis M, Caramelli F, Pasero DC, Pala G, Renzini M, Conte M, Paternoster G, Martinez B, Pinelli F, Frontini M, Zucchetti MC, Pappalardo F, Amantea B, Camata A, Pisano A, Verdecchia C, Dal Checco E, Cariello C, Faita L, Baldassarri R, Scandroglio AM, Saleh O, Lembo R, Calabro MG, Bellomo R, Landoni G. Effect of fenoldopam on use of renal replacement therapy among patients with acute kidney injury after cardiac surgery: a randomized clinical trial. JAMA. 2014 Dec 3;312(21):2244-53. doi: 10.1001/jama.2014.13573.
Other Identifiers
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GO/URC/ER/mm 64/DG
Identifier Type: -
Identifier Source: org_study_id
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