Fenoldopam and Acute Renal Failure

NCT ID: NCT00621790

Last Updated: 2015-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

667 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Acute Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fenoldopam

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

Group Type EXPERIMENTAL

fenoldopam

Intervention Type DRUG

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

Placebo

Placebo (normosaline), continuous perfusion

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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fenoldopam

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

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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corlopam

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Landoni

Head of Research, Anesthesia and Intensive Care Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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A.O. Universitario Policlinico S.Orsola Malpighi

Bologna, , Italy

Site Status

Pres.Ospedal. Spedali Civili Brescia - Brescia

Brescia, , Italy

Site Status

Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro

Catanzaro, , Italy

Site Status

Azienda Ospedaliero Universitaria Careggi - Firenze

Florence, , Italy

Site Status

Città di Lecce Hospital GVM Care and Research Lecce

Lecce, , Italy

Site Status

Villa Maria Cecilia di Cotignola

Lugo Di Ravenna, , Italy

Site Status

Azienda Ospedaliera Papardo - Messina

Messina, , Italy

Site Status

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

Milan, , Italy

Site Status

Azienda Ospedaliera Vincenzo Monaldi - Napoli

Napoli, , Italy

Site Status

Azienda Ospedaliera di Padova

Padua, , Italy

Site Status

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

Perugia, , Italy

Site Status

Azienda Ospedaliero Universitaria Pisana - Pisa

Pisa, , Italy

Site Status

A.O.Universitario Policlinico Tor Vergata - Roma

Roma, , Italy

Site Status

Ospedale Civile SS Annunziata di Sassari

Sassari, , Italy

Site Status

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

Siena, , Italy

Site Status

Azienda Ospedaliera San Giovanni Battista Molinette di Torino

Torino, , Italy

Site Status

Ospedale Mauriziano Umberto I di Torino

Torino, , Italy

Site Status

Ospedale S.Maria di Ca' Foncello

Treviso, , Italy

Site Status

Azienda Ospedaliera Universitaria Santa Maria della Misericordia

Udine, , Italy

Site Status

Countries

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Italy

References

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Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.

Reference Type DERIVED
PMID: 39607014 (View on PubMed)

Bove T, Zangrillo A, Guarracino F, Alvaro G, Persi B, Maglioni E, Galdieri N, Comis M, Caramelli F, Pasero DC, Pala G, Renzini M, Conte M, Paternoster G, Martinez B, Pinelli F, Frontini M, Zucchetti MC, Pappalardo F, Amantea B, Camata A, Pisano A, Verdecchia C, Dal Checco E, Cariello C, Faita L, Baldassarri R, Scandroglio AM, Saleh O, Lembo R, Calabro MG, Bellomo R, Landoni G. Effect of fenoldopam on use of renal replacement therapy among patients with acute kidney injury after cardiac surgery: a randomized clinical trial. JAMA. 2014 Dec 3;312(21):2244-53. doi: 10.1001/jama.2014.13573.

Reference Type DERIVED
PMID: 25265449 (View on PubMed)

Other Identifiers

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GO/URC/ER/mm 64/DG

Identifier Type: -

Identifier Source: org_study_id

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