NCT01440881

Does Nesiritide Provide Renal Protection

Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 30-90ml/min. Patients were randomized to either placebo or nesiritide (administered prophylactically starting in the operating room prior to incision at 0.01 mcg/kg /minute with no bolus and continued for 48 hours).

Conditions

• Renal Failure

Interventions

Type	Name	Description
DRUG	Nesiritide	infuses at 0.01MCG/KG/min for 48 hours
DRUG	Placebo	infuses at 0.01MCG/KG/min for 48 hours

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-09-27
• Last updated: 2014-06-06
• Results posted: 2014-03-06

Locations

1 site across 1 country: United States