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Fenoldopam and Acute Renal Failure (FENO HSR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621790
First Posted: February 22, 2008
Last Update Posted: October 14, 2015
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.
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
February 12, 2008
February 22, 2008
October 14, 2015
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 ]
Renal Replacement Therapy [ Time Frame: Intensive Care Unit Stay ]
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. ]
Mortality [ Time Frame: INtensive Care Unit, Hospital, 30 days, 1 year ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
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, Calabrò 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.

*   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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00621790
GO/URC/ER/mm 64/DG
Not Provided
Not Provided
Not Provided
Giovanni Landoni, Università Vita-Salute San Raffaele
Università Vita-Salute San Raffaele
Not Provided
Not Provided
Università Vita-Salute San Raffaele
October 2015

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