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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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 |
- 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 ]
- 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 |
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 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 Therapeutic Uses Pharmacologic Actions Vasodilator Agents |
Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013