Fenoldopam and Acute Renal Failure (FENO HSR)

Università Vita-Salute San Raffaele

Status and phase: Completed; Phase 3

Conditions: Acute Renal Failure

Treatments: Drug: fenoldopam; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00621790

GO/URC/ER/mm 64/DG

Details and patient eligibility

About

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.

Enrollment: 667 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

667 participants in 2 patient groups, including a placebo group

Fenoldopam

Experimental group

Description:

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

Treatment:

Drug: fenoldopam

Placebo

Placebo Comparator group

Description:

Placebo (normosaline), continuous perfusion

Treatment:

Drug: placebo