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Does Nesiritide Provide Renal Protection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01440881
First received: February 10, 2011
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Renal Failure
Drug: Nesiritide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Measure Neutrophils to Measure Kidney Injury [ Time Frame: 30 days from the start of infusion ] [ Designated as safety issue: No ]
    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.

  • The Examine and Measure Cytokines to Measure Kidney Injury [ Time Frame: 30 days from the start of infusion ] [ Designated as safety issue: No ]
    Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines.

  • The Examine and Measure Endothelin-1 to Measure Kidney Injury [ Time Frame: 30 days from the start of infusion ] [ Designated as safety issue: No ]
    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.

  • The Examine and Measure Urinary NGAL to Measure Kidney Injury [ Time Frame: A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed. ] [ Designated as safety issue: No ]
    Urinary NGAL,a biomarker for kidney injury was measured.


Enrollment: 37
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nesiritide
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
Drug: Nesiritide
infuses at 0.01MCG/KG/min for 48 hours
Other Name: kidney protection post cardiopulmonary bypass.
Placebo Comparator: Placebo
infuses at 0.01MCG/KG/min for 48 hours
Drug: Placebo
infuses at 0.01MCG/KG/min for 48 hours
Other Name: kidney protection post cardiopulmonary bypass

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440881

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Thomas Beaver, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01440881     History of Changes
Other Study ID Numbers: 70-2010, 09KW-03
Study First Received: February 10, 2011
Results First Received: January 22, 2014
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
renal failure
cardiopulmonary bypass

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014