Fenoldopam and Acute Renal Failure (FENO HSR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT00621790
First received: February 12, 2008
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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
Acute Renal Failure
Drug: fenoldopam
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of dead patients. [ Time Frame: Participants will be followed for 1 year. ] [ Designated as safety issue: No ]

Enrollment: 667
Study Start Date: February 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenoldopam
Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days
Drug: fenoldopam
fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
Other Name: corlopam
Placebo Comparator: Placebo
Placebo (normosaline), continuous perfusion
Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621790

Locations
Italy
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
Firenze, 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
Milano, Italy, 20132
Azienda Ospedaliera Vincenzo Monaldi - Napoli
Napoli, Italy
Azienda Ospedaliera di Padova
Padova, 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
Ospedale Mauriziano Umberto I di Torino
Torino, Italy
Azienda Ospedaliera San Giovanni Battista Molinette di Torino
Torino, Italy
Ospedale S.Maria di Ca' Foncello
Treviso, Italy
Azienda Ospedaliera Universitaria Santa Maria della Misericordia
Udine, Italy
Sponsors and Collaborators
Università Vita-Salute San Raffaele
  More Information

No publications provided

Responsible Party: Giovanni Landoni, Head of Research, Anesthesia and Intensive Care Department, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT00621790     History of Changes
Other Study ID Numbers: GO/URC/ER/mm 64/DG
Study First Received: February 12, 2008
Last Updated: August 2, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
fenoldopam
acute renal failure
renal replacement therapy
mortality
cardiac surgery
cardiac anesthesia
intensive care unit

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Fenoldopam
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014