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Completed

NCT Number: NCT01440881

Does Nesiritide Provide Renal Protection

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

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nesiritide

Drug

infuses at 0.01MCG/KG/min for 48 hours

Other names: kidney protection post cardiopulmonary bypass.

Placebo

Drug

infuses at 0.01MCG/KG/min for 48 hours

Other names: kidney protection post cardiopulmonary bypass

Primary outcomes

  1. Measure Neutrophils to Measure Kidney Injury

    Time frame: 30 days from the start of infusion

    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.

  2. The Examine and Measure Cytokines to Measure Kidney Injury

    Time frame: 30 days from the start of infusion

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

  3. The Examine and Measure Endothelin-1 to Measure Kidney Injury

    Time frame: 30 days from the start of infusion

    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.

  4. 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.

    Urinary NGAL,a biomarker for kidney injury was measured.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 27, 2011
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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