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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.
Information provided by:
Summa Health System Identifier:
First received: April 26, 2007
Last updated: January 28, 2008
Last verified: April 2007

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


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

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
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Please refer to this study by its identifier: NCT00467181

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

Responsible Party: Dr. William Fallon, Summa Health System Identifier: NCT00467181     History of Changes
Other Study ID Numbers: RP05009
Study First Received: April 26, 2007
Last Updated: January 28, 2008

Keywords provided by Summa Health System:
cardiac surgery
renal dysfunction

Additional relevant MeSH terms:
Antihypertensive Agents
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on August 21, 2017