Status:
COMPLETED
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
Lead Sponsor:
Summa Health System
Conditions:
Cardiac Surgery With Cardiopulmonary Bypass
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 d...
Detailed Description
Although all patients undergoing cardiac surgery are at risk for renal dysfunction, there are certain preoperative clinical parameters which have been shown to place patients at particularly high risk...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00467181
Start Date
January 1 2005
End Date
April 1 2006
Last Update
January 30 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Summa Health System
Akron, Ohio, United States, 44304