Status:
COMPLETED
Does Nesiritide Provide Renal Protection
Lead Sponsor:
University of Florida
Conditions:
Renal Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.
Detailed Description
This will be a randomized, prospective blinded pilot study comparing nesiritide to placebo in patients undergoing aortic arch, ascending aorta, aortic valve or mitral valve surgery with baseline GFR 3...
Eligibility Criteria
Inclusion
- Patients undergoing surgery on their aortic arch, ascending aorta, or having aortic valve or mitral valve surgery
- Baseline MDRD (modification of diet in renal disease) calculated GFR (Glomerular Filtration Rate) 30-90 ml/min.
- Signed Informed Consent
Exclusion
- Age \<18 or \>80
- Ejection Fraction \<30%.
- Presence of endocarditis or other infection.
- Presence or anticipated use of an intra-aortic balloon pump.
- History of an organ transplant.
- History of an adverse reaction to nesiritide.
- Surgery performed without cardiopulmonary bypass.
- Receiving Aprotinin
- Dopamine administered in doses \<5 mcg /kg min.
- Women of child bearing potential or pregnant or breastfeeding.
- Participation in any other investigational trial
- Jehovah Witness
- Bleeding Disorder
- Active Endocarditis
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01440881
Start Date
April 1 2010
End Date
December 1 2012
Last Update
June 6 2014
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610