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Fenoldopam and Acute Renal Failure (FENO HSR)

Primary Purpose

Acute Renal Failure

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
fenoldopam
placebo
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Renal Failure focused on measuring fenoldopam, acute renal failure, renal replacement therapy, mortality, cardiac surgery, cardiac anesthesia, intensive care unit

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.O. Universitario Policlinico S.Orsola Malpighi
  • Pres.Ospedal. Spedali Civili Brescia - Brescia
  • Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro
  • Azienda Ospedaliero Universitaria Careggi - Firenze
  • Città di Lecce Hospital GVM Care and Research Lecce
  • Villa Maria Cecilia di Cotignola
  • Azienda Ospedaliera Papardo - Messina
  • Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
  • Azienda Ospedaliera Vincenzo Monaldi - Napoli
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera di Perugia - Policlinico Monteluce(Osp. S.Maria della Misericordia)
  • Azienda Ospedaliero Universitaria Pisana - Pisa
  • A.O.Universitario Policlinico Tor Vergata - Roma
  • Ospedale Civile SS Annunziata di Sassari
  • Azienda Ospedaliera Universitaria Senese (Policlinico S.Maria alle Scotte)
  • Azienda Ospedaliera San Giovanni Battista Molinette di Torino
  • Ospedale Mauriziano Umberto I di Torino
  • Ospedale S.Maria di Ca' Foncello
  • Azienda Ospedaliera Universitaria Santa Maria della Misericordia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fenoldopam

Placebo

Arm Description

Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days

Placebo (normosaline), continuous perfusion

Outcomes

Primary Outcome Measures

Number of patients requiring Renal Replacement Therapy

Secondary Outcome Measures

Number of dead patients.

Full Information

First Posted
February 12, 2008
Last Updated
October 13, 2015
Sponsor
Università Vita-Salute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT00621790
Brief Title
Fenoldopam and Acute Renal Failure
Acronym
FENO HSR
Official Title
Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure
Keywords
fenoldopam, acute renal failure, renal replacement therapy, mortality, cardiac surgery, cardiac anesthesia, intensive care unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fenoldopam
Arm Type
Experimental
Arm Description
Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (normosaline), continuous perfusion
Intervention Type
Drug
Intervention Name(s)
fenoldopam
Other Intervention Name(s)
corlopam
Intervention Description
fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of dead patients.
Time Frame
Participants will be followed for 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
A.O. Universitario Policlinico S.Orsola Malpighi
City
Bologna
Country
Italy
Facility Name
Pres.Ospedal. Spedali Civili Brescia - Brescia
City
Brescia
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro
City
Catanzaro
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi - Firenze
City
Firenze
Country
Italy
Facility Name
Città di Lecce Hospital GVM Care and Research Lecce
City
Lecce
Country
Italy
Facility Name
Villa Maria Cecilia di Cotignola
City
Lugo di Ravenna
Country
Italy
Facility Name
Azienda Ospedaliera Papardo - Messina
City
Messina
Country
Italy
Facility Name
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera Vincenzo Monaldi - Napoli
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia - Policlinico Monteluce(Osp. S.Maria della Misericordia)
City
Perugia
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana - Pisa
City
Pisa
Country
Italy
Facility Name
A.O.Universitario Policlinico Tor Vergata - Roma
City
Roma
Country
Italy
Facility Name
Ospedale Civile SS Annunziata di Sassari
City
Sassari
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese (Policlinico S.Maria alle Scotte)
City
Siena
Country
Italy
Facility Name
Azienda Ospedaliera San Giovanni Battista Molinette di Torino
City
Torino
Country
Italy
Facility Name
Ospedale Mauriziano Umberto I di Torino
City
Torino
Country
Italy
Facility Name
Ospedale S.Maria di Ca' Foncello
City
Treviso
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Santa Maria della Misericordia
City
Udine
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25265449
Citation
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, 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.
Results Reference
derived

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Fenoldopam and Acute Renal Failure

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