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Fenoldopam and Acute Renal Failure

Information source: UniversitÓ Vita-Salute San Raffaele
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Renal Failure

Intervention: fenoldopam (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UniversitÓ Vita-Salute San Raffaele

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of patients requiring Renal Replacement Therapy

Secondary outcome: Number of dead patients.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

A.O. Universitario Policlinico S.Orsola Malpighi, Bologna, Italy

Pres.Ospedal. Spedali Civili Brescia - Brescia, Brescia, Italy

Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro, Catanzaro, 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

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia, Milano 20132, Italy

Azienda Ospedaliera Vincenzo Monaldi - Napoli, Napoli, Italy

Azienda Ospedaliera di Padova, Padova, Italy

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

Azienda Ospedaliero Universitaria Pisana - Pisa, Pisa, Italy

A.O.Universitario Policlinico Tor Vergata - Roma, Roma, Italy

Ospedale Civile SS Annunziata di Sassari, Sassari, Italy

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

Azienda Ospedaliera San Giovanni Battista Molinette di Torino, Torino, Italy

Ospedale Mauriziano Umberto I di Torino, Torino, Italy

Ospedale S.Maria di Ca' Foncello, Treviso, Italy

Azienda Ospedaliera Universitaria Santa Maria della Misericordia, Udine, Italy

Additional Information

Starting date: February 2008
Last updated: August 2, 2013

Page last updated: August 23, 2015

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