Fenoldopam and Acute Renal Failure

Università Vita-Salute San Raffaele667 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

667

Conditions

Acute Renal Failure

Interventions

fenoldopamDRUG

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

placeboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (19)

A.O. Universitario Policlinico S.Orsola Malpighi

Bologna, Italy

Pres.Ospedal. Spedali Civili Brescia - Brescia

Brescia, Italy

Outcomes

Primary Outcomes

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 Outcomes

Number of dead patients.

Time frame: Participants will be followed for 1 year.

Data from ClinicalTrials.gov

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