Does Nesiritide Provide Renal Protection

University of Florida37 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Renal Failure

Interventions

NesiritideDRUG

infuses at 0.01MCG/KG/min for 48 hours

PlaceboDRUG

infuses at 0.01MCG/KG/min for 48 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Measure Neutrophils to Measure Kidney Injury

0.35 mL of whole blood from each patient was applied to a microfluidics chip to isolate neutrophils. Total RNA was subsequently isolated and gene expression (for all genes listed below) was measured with an Affymetrix gene chip. Data was normalized using RMA (Robust multi-array average) and expressed as log2 expression.

Time frame: 30 days from the start of infusion

The Examine and Measure Cytokines to Measure Kidney Injury

Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines.

Time frame: 30 days from the start of infusion

The Examine and Measure Endothelin-1 to Measure Kidney Injury

Serial measurements of Endothelin-1 levels were measured to determine if natriuretic peptides exert their renal protective effects by preserving renal afferent arteriole flow by antagonizing the vasoconstrictive effects of Endothelin-1.

Time frame: 30 days from the start of infusion

The Examine and Measure Urinary NGAL to Measure Kidney Injury

Urinary NGAL,a biomarker for kidney injury was measured.

Time frame: A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.