Fenoldopam and Acute Renal Failure
FENO HSR
Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.
1 other identifier
interventional
667
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2008
Longer than P75 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 12, 2008
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 14, 2015
October 1, 2015
5.3 years
February 12, 2008
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients requiring Renal Replacement Therapy
participants will be followed for the duration of intensive care unit stay, an expected average of one week
Secondary Outcomes (1)
Number of dead patients.
Participants will be followed for 1 year.
Study Arms (2)
Fenoldopam
EXPERIMENTALFenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days
Placebo
PLACEBO COMPARATORPlacebo (normosaline), continuous perfusion
Interventions
fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
Eligibility Criteria
You may qualify if:
- adult patients
- who underwent cardiac surgery
- have Risk of Acute Renal Failure (R of RIFLE score)
You may not qualify if:
- glaucoma
- already on renal replacement therapy
- study drug in the past 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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, 20132, 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
Related Publications (2)
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.
PMID: 39607014DERIVEDBove 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.
PMID: 25265449DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Research, Anesthesia and Intensive Care Department
Study Record Dates
First Submitted
February 12, 2008
First Posted
February 22, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 14, 2015
Record last verified: 2015-10