Does Nesiritide Provide Renal Protection

University of Florida

Status and phase: Completed; Phase 2

Conditions: Renal Failure

Treatments: Drug: Nesiritide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01440881

70-2010

09KW-03 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 2 patient groups, including a placebo group

Nesiritide

Active Comparator group

Description:

infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours

Treatment:

Drug: Nesiritide

Placebo

Placebo Comparator group

Description:

infuses at 0.01MCG/KG/min for 48 hours

Treatment:

Drug: Placebo