FENO HSR: Fenoldopam and Acute Renal Failure

Sponsor

Università Vita-Salute San Raffaele (Other)

Overall Status

Completed

CT.gov ID

NCT00621790

Collaborator

(none)

667

Enrollment

Locations

Arms

Duration (Months)

35.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Renal Failure	Drug: fenoldopam Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

667 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fenoldopam Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days	Drug: fenoldopam fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days Other Names: corlopam
Placebo Comparator: Placebo Placebo (normosaline), continuous perfusion	Drug: placebo placebo

Arm

Intervention/Treatment

Experimental: Fenoldopam

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

Drug: fenoldopam

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

Other Names:

corlopam

Placebo Comparator: Placebo

Placebo (normosaline), continuous perfusion

Drug: placebo

placebo

Outcome Measures

Primary Outcome Measures

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

Number of dead patients. [Participants will be followed for 1 year.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	A.O. Universitario Policlinico S.Orsola Malpighi	Bologna	Italy
2	Pres.Ospedal. Spedali Civili Brescia - Brescia	Brescia	Italy
3	Azienda Ospedaliera Universitaria "Mater Domini" Catanzaro	Catanzaro	Italy
4	Azienda Ospedaliero Universitaria Careggi - Firenze	Firenze	Italy
5	Città di Lecce Hospital GVM Care and Research Lecce	Lecce	Italy
6	Villa Maria Cecilia di Cotignola	Lugo di Ravenna	Italy
7	Azienda Ospedaliera Papardo - Messina	Messina	Italy
8	Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia	Milano	Italy	20132
9	Azienda Ospedaliera Vincenzo Monaldi - Napoli	Napoli	Italy
10	Azienda Ospedaliera di Padova	Padova	Italy
11	Azienda Ospedaliera di Perugia - Policlinico Monteluce(Osp. S.Maria della Misericordia)	Perugia	Italy
12	Azienda Ospedaliero Universitaria Pisana - Pisa	Pisa	Italy
13	A.O.Universitario Policlinico Tor Vergata - Roma	Roma	Italy
14	Ospedale Civile SS Annunziata di Sassari	Sassari	Italy
15	Azienda Ospedaliera Universitaria Senese (Policlinico S.Maria alle Scotte)	Siena	Italy
16	Azienda Ospedaliera San Giovanni Battista Molinette di Torino	Torino	Italy
17	Ospedale Mauriziano Umberto I di Torino	Torino	Italy
18	Ospedale S.Maria di Ca' Foncello	Treviso	Italy
19	Azienda Ospedaliera Universitaria Santa Maria della Misericordia	Udine	Italy