Does Nesiritide Provide Renal Protection

Renal Failure Clinical Trial

Official title:

Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440881
• Other study ID #: 70-2010
• Secondary ID: 09KW-03
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2011
• Last updated: May 16, 2014
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Nesiritide
infuses at 0.01MCG/KG/min for 48 hours
• Placebo
infuses at 0.01MCG/KG/min for 48 hours

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days from the start of infusion	No
Primary	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.	30 days from the start of infusion	No
Primary	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.	30 days from the start of infusion	No
Primary	The Examine and Measure Urinary NGAL to Measure Kidney Injury	Urinary NGAL,a biomarker for kidney injury was measured.	A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.	No