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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:
Information provided by:
Summa Health System
ClinicalTrials.gov Identifier:
NCT00467181
First received: April 26, 2007
Last updated: January 28, 2008
Last verified: April 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. William Fallon, Summa Health System
ClinicalTrials.gov Identifier: NCT00467181     History of Changes
Other Study ID Numbers: RP05009
Study First Received: April 26, 2007
Last Updated: January 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
cardiac surgery
renal dysfunction

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

ClinicalTrials.gov processed this record on November 25, 2014