Does Nesiritide Provide Renal Protection

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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