Fenoldopam and Acute Renal Failure (FENO HSR)

October 13, 2015 updated by: Giovanni Landoni, Università Vita-Salute San Raffaele

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

667

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • A.O. Universitario Policlinico S.Orsola Malpighi
      • Brescia, Italy
        • Pres.Ospedal. Spedali Civili Brescia - Brescia
      • Catanzaro, Italy
        • Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro
      • Firenze, Italy
        • Azienda Ospedaliero Universitaria Careggi - Firenze
      • Lecce, Italy
        • Città di Lecce Hospital GVM Care and Research Lecce
      • Lugo di Ravenna, Italy
        • Villa Maria Cecilia di Cotignola
      • Messina, Italy
        • Azienda Ospedaliera Papardo - Messina
      • Milano, Italy, 20132
        • Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
      • Napoli, Italy
        • Azienda Ospedaliera Vincenzo Monaldi - Napoli
      • Padova, Italy
        • Azienda Ospedaliera di Padova
      • Perugia, Italy
        • Azienda Ospedaliera di Perugia - Policlinico Monteluce(Osp. S.Maria della Misericordia)
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana - Pisa
      • Roma, Italy
        • A.O.Universitario Policlinico Tor Vergata - Roma
      • Sassari, Italy
        • Ospedale Civile SS Annunziata di Sassari
      • Siena, Italy
        • Azienda Ospedaliera Universitaria Senese (Policlinico S.Maria alle Scotte)
      • Torino, Italy
        • Azienda Ospedaliera San Giovanni Battista Molinette di Torino
      • Torino, Italy
        • Ospedale Mauriziano Umberto I di Torino
      • Treviso, Italy
        • Ospedale S.Maria di Ca' Foncello
      • Udine, Italy
        • Azienda Ospedaliera Universitaria Santa Maria della Misericordia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • corlopam
Placebo Comparator: Placebo
Placebo (normosaline), continuous perfusion
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
participants will be followed for the duration of intensive care unit stay, an expected average of one week

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of dead patients.
Time Frame: Participants will be followed for 1 year.
Participants will be followed for 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO/URC/ER/mm 64/DG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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