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Fenoldopam and Acute Renal Failure

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00621790
Acronym
FENO HSR
Enrollment
667
Registered
2008-02-22
Start date
2008-02-29
Completion date
2013-06-30
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure

Keywords

fenoldopam, acute renal failure, renal replacement therapy, mortality, cardiac surgery, cardiac anesthesia, intensive care unit

Brief 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.

Interventions

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

DRUGplacebo

placebo

Sponsors

Università Vita-Salute San Raffaele
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients requiring Renal Replacement Therapyparticipants will be followed for the duration of intensive care unit stay, an expected average of one week

Secondary

MeasureTime frame
Number of dead patients.Participants will be followed for 1 year.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026