Fenoldopam and Acute Renal Failure - Full Text View

Sponsored by:	Università Vita-Salute San Raffaele
Information provided by:	Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:	NCT00621790

Purpose

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.

Condition	Intervention	Phase
Acute Renal Failure	Drug: fenoldopam Drug: placebo	Phase III

MedlinePlus related topics: Heart Surgery Kidney Failure

Drug Information available for: Fenoldopam mesylate Fenoldopam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:

Renal Replacement Therapy [ Time Frame: Intensive Care Unit Stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mortality [ Time Frame: INtensive Care Unit, Hospital, 30 days, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator Placebo (normosaline), continuous perfusion	Drug: placebo placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621790

Contacts

Contact: giovanni landoni, MD	+39.347.2520801	landoni.giovanni@hsr.it
Contact: tiziana bove, MD	+39.02.26434524	bove.tiziana@hsr.it

Locations

Italy
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia	Recruiting
Milano, Italy, 20132
Sub-Investigator: giovanni marino, MD

Sponsors and Collaborators

Università Vita-Salute San Raffaele

More Information

Study ID Numbers:	GO/URC/ER/mm 64/DG
Study First Received:	February 12, 2008
Last Updated:	February 24, 2008
ClinicalTrials.gov Identifier:	NCT00621790
Health Authority:	Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:

fenoldopam
acute renal failure
renal replacement therapy
mortality

cardiac surgery
cardiac anesthesia
intensive care unit

Study placed in the following topic categories:

Renal Insufficiency
Dopamine
Urologic Diseases
Fenoldopam

Renal Insufficiency, Acute
Kidney Diseases
Kidney Failure, Acute
Kidney Failure

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Dopamine Agents
Cardiovascular Agents
Dopamine Agonists
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009