Fenoldopam and Acute Renal Failure (FENO HSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00621790
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

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.

Condition or disease Intervention/treatment Phase
Acute Renal Failure Drug: fenoldopam Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 667 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : February 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Fenoldopam

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of dead patients. [ Time Frame: Participants will be followed for 1 year. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00621790

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
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
Sponsors and Collaborators
Università Vita-Salute San Raffaele

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Giovanni Landoni, Head of Research, Anesthesia and Intensive Care Department, Università Vita-Salute San Raffaele Identifier: NCT00621790     History of Changes
Other Study ID Numbers: GO/URC/ER/mm 64/DG
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

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

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