Clinical trial NCT00621790: Fenoldopam and Acute Renal Failure
Official title: Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Renal Failure
Keywords: fenoldopam
acute renal failure
renal replacement therapy
mortality
cardiac surgery
cardiac anesthesia
intensive care unit
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* adult patients
* who underwent cardiac surgery
* have Risk of Acute Renal Failure (R of RIFLE score)

Exclusion Criteria:

* glaucoma
* already on renal replacement therapy
* study drug in the past 30 days
* inclusion in other protocols

Primary outcomes:
measure: Number of patients requiring Renal Replacement Therapy
timeFrame: participants will be followed for the duration of intensive care unit stay, an expected average of one week
Secondary outcomes:
measure: Number of dead patients.
timeFrame: Participants will be followed for 1 year.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: A.O. Universitario Policlinico S.Orsola Malpighi
city: Brescia
country: Italy
facility: Pres.Ospedal. Spedali Civili Brescia - Brescia
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi - Firenze
city: Lecce
country: Italy
facility: Città di Lecce Hospital GVM Care and Research Lecce
city: Lugo di Ravenna
country: Italy
facility: Villa Maria Cecilia di Cotignola
city: Messina
country: Italy
facility: Azienda Ospedaliera Papardo - Messina
city: Milano
country: Italy
facility: Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
city: Napoli
country: Italy
facility: Azienda Ospedaliera Vincenzo Monaldi - Napoli
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce(Osp. S.Maria della Misericordia)
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Pisa
city: Roma
country: Italy
facility: A.O.Universitario Policlinico Tor Vergata - Roma
city: Sassari
country: Italy
facility: Ospedale Civile SS Annunziata di Sassari
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese (Policlinico S.Maria alle Scotte)
city: Torino
country: Italy
facility: Azienda Ospedaliera San Giovanni Battista Molinette di Torino
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I di Torino
city: Treviso
country: Italy
facility: Ospedale S.Maria di Ca' Foncello
city: Udine
country: Italy
facility: Azienda Ospedaliera Universitaria Santa Maria della Misericordia
Study officials:
References:
citation: 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.