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: January 22, 2014
Last verified: January 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:
  • The Examine and Measure Neutrophils to Measure Kidney Injury [ Time Frame: start on infusing through 30 days. ] [ Designated as safety issue: No ]
    Microfluidics technology are examined the genomic expression patterns in circulating neutrophils.Neutrophils isolated from both serum&urine.

  • The Examine and Measure Cytokines to Measure Kidney Injury [ Time Frame: start on infusing through 30 days. ] [ 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: start on infusing through 30 days. ] [ 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: start on infusing through 30 days. ] [ 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
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: January 22, 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
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014