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A Pilot Study to Investigate Fenoldopam Usage in the Prevention of Postoperative Renal Dysfunction in Patients at a High Risk for Renal Impairment During Cariopulmonary Bypass for Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467181
First Posted: April 27, 2007
Last Update Posted: January 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Summa Health System
  Purpose

The Primary objective is to reduce the incidence of postoperative renal dysfunction in a high-risk subset of patients undergoing cardiac surgery on cardiopulmonary bypass with Fenolopam, a selective dopamine-1 receptor agonist. Perioperative renal function will be observed in 3 randomly selected groups of patients-Fenoldopam infusion at 0.03 cg/kg/min, Fenoldopam at 0.1 mcg/kg/min or placebo

Secondary objective: will be to correlate Fenoldopam usage with postoperative clinical outcomes such as ICU stay, hospital stay, need for inotropes/vasopressors, need for diuretics, requirements for ECF at discharge, and overall perioperative cost reduction through decreased ICU and hospital length of stay.


Condition Intervention Phase
Cardiac Surgery With Cardiopulmonary Bypass Drug: Fenoldopam Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Summa Health System:

Primary Outcome Measures:
  • To evaluate postop renal dysfunction in patients undergoing cardiac surgery. Post-op creatinine, urine output, and progression to renal dysfunction will be observed. Renal dysfunction will be defined as an increase in [ Time Frame: During Stay ]

Secondary Outcome Measures:
  • Length of ICU and hospital stay, ventilator requirements,need for diuretics, or perioperative inotropes/vasopressors, and need for discharge to extended care facilities. [ Time Frame: Length of stay ]

Estimated Enrollment: 30
Study Start Date: January 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients undergoing CABG, CABG/valve operations must meet one of the following:

  • Age greater than 70
  • Preoperative (within one week) creatinine > or = 1.3
  • Insulin depenent diabetes
  • NYHA CHF class 3 or 4
  • Bypass time anticipated to be greater than 3 hours
  • Redo coronary artery bypass grafting
  • Low cardiac output states -need for inotropic agents or IABP preoperatively

Exclusion Criteria:

  • Emergent operations
  • Preopertive liver failure
  • Preopertive acute or chronic dialysis dependence
  • Known allergy to Fenoldopam
  • Patients in whom usage of dopaminergic medications are contraindicated
  • Age less than 30
  • Caridac surgery without cardiopulmonary bypass
  • Patients acively participating in other clinical trials
  • Usage of dopaminergic medication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467181


Locations
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Sponsors and Collaborators
Summa Health System
Investigators
Principal Investigator: Marion Hochstetler, MD Summa Health System
  More Information

Responsible Party: Dr. William Fallon, Summa Health System
ClinicalTrials.gov Identifier: NCT00467181     History of Changes
Other Study ID Numbers: RP05009
First Submitted: April 26, 2007
First Posted: April 27, 2007
Last Update Posted: January 30, 2008
Last Verified: April 2007

Keywords provided by Summa Health System:
cardiac surgery
renal dysfunction

Additional relevant MeSH terms:
Fenoldopam
Antihypertensive Agents
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs