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NCT00621790 Clinical Trial

Fenoldopam and Acute Renal Failure

Acute Renal Failure Clinical Trial

— FENO HSR  

Official title:
Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00621790
Other study ID # GO/URC/ER/mm 64/DG
Secondary ID
Status Completed
Phase Phase 3
First received February 12, 2008
Last updated October 13, 2015
Start date February 2008
Est. completion date June 2013

Study information
Verified date October 2015
Source Università Vita-Salute San Raffaele
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 667
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 99 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• fenoldopam
fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days
• placebo
placebo

Locations
Country Name City State
Italy 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 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

Sponsors (1)
Lead Sponsor Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients requiring Renal Replacement Therapy participants will be followed for the duration of intensive care unit stay, an expected average of one week No
Secondary Number of dead patients. Participants will be followed for 1 year. No
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