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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

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ClinicalTrials.gov Identifier: NCT00467181
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : January 30, 2008
Sponsor:
Information provided by:
Summa Health System

Brief Summary:

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 or disease Intervention/treatment Phase
Cardiac Surgery With Cardiopulmonary Bypass Drug: Fenoldopam Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : January 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Fenoldopam
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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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

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

Responsible Party: Dr. William Fallon, Summa Health System
ClinicalTrials.gov Identifier: NCT00467181     History of Changes
Other Study ID Numbers: RP05009
First Posted: April 27, 2007    Key Record Dates
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