Fenoldopam and Acute Renal Failure

Phase 3

Completed

• Conditions: Acute Renal Failure
• Interventions: Drug: placebo; Drug: fenoldopam

• Registration Number: NCT00621790
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo (normosaline), continuous perfusion
Fenoldopam	fenoldopam	Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of dead patients.	Participants will be followed for 1 year.

Trial Locations

Locations (19)

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia; 🇮🇹 Milano, Italy

Pres.Ospedal. Spedali Civili Brescia - Brescia; 🇮🇹 Brescia, Italy

Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro; 🇮🇹 Catanzaro, Italy

A.O. Universitario Policlinico S.Orsola Malpighi; 🇮🇹 Bologna, 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

Azienda Ospedaliera Vincenzo Monaldi - Napoli; 🇮🇹 Napoli, Italy

Azienda Ospedaliera di Perugia - Policlinico Monteluce(Osp. S.Maria della Misericordia); 🇮🇹 Perugia, Italy

Azienda Ospedaliero Universitaria Pisana - Pisa; 🇮🇹 Pisa, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Azienda Ospedaliera Universitaria Senese (Policlinico S.Maria alle Scotte); 🇮🇹 Siena, Italy

A.O.Universitario Policlinico Tor Vergata - Roma; 🇮🇹 Roma, Italy

Ospedale Civile SS Annunziata di Sassari; 🇮🇹 Sassari, Italy

Ospedale Mauriziano Umberto I di Torino; 🇮🇹 Torino, Italy

Azienda Ospedaliera San Giovanni Battista Molinette di Torino; 🇮🇹 Torino, Italy

Azienda Ospedaliera Universitaria Santa Maria della Misericordia; 🇮🇹 Udine, Italy

Ospedale S.Maria di Ca' Foncello; 🇮🇹 Treviso, Italy