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OpenTrials
Completed

NCT Number: NCT00621790

Fenoldopam and Acute Renal Failure

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.

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Key information

Conditions

Acute Renal Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fenoldopam

Drug

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

Other names: corlopam

Placebo

Drug

placebo

Primary outcomes

  1. Number of patients requiring Renal Replacement Therapy

    Time frame: participants will be followed for the duration of intensive care unit stay, an expected average of one week

Secondary outcomes

  1. Number of dead patients.

    Time frame: Participants will be followed for 1 year.

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

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

Acronym: FENO HSR

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 22, 2008
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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