Does Nesiritide Provide Renal Protection

Completed · Phase 2 · Has a placebo group

Conditions studied: Renal Failure

In brief

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

Key facts

Study ID

NCT01440881

Run by

University of Florida

People needed

37

Starts

2010-04-01

Expected to finish

2012-12-01

Last updated by the study team

2014-06-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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