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

February 12, 2008
August 2, 2013
February 2008
June 2013   (final data collection date for primary outcome measure)
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 ]
Renal Replacement Therapy [ Time Frame: Intensive Care Unit Stay ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00621790 on ClinicalTrials.gov Archive Site
Number of dead patients. [ Time Frame: Participants will be followed for 1 year. ] [ Designated as safety issue: No ]
Mortality [ Time Frame: INtensive Care Unit, Hospital, 30 days, 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Fenoldopam and Acute Renal Failure
Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Renal Failure
  • 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
  • Drug: placebo
    placebo
  • Experimental: Fenoldopam
    Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days
    Intervention: Drug: fenoldopam
  • Placebo Comparator: Placebo
    Placebo (normosaline), continuous perfusion
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
667
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00621790
GO/URC/ER/mm 64/DG
Not Provided
Giovanni Landoni, Università Vita-Salute San Raffaele
Università Vita-Salute San Raffaele
Not Provided
Not Provided
Università Vita-Salute San Raffaele
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP