Back to resultsDoes Nesiritide Provide Renal Protection
Primary Purpose
Renal Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nesiritide
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Renal Failure focused on measuring renal failure, cardiopulmonary bypass
Eligibility 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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nesiritide
Placebo
Arm Description
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
infuses at 0.01MCG/KG/min for 48 hours
Outcomes
Primary Outcome Measures
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.
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.
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.
The Examine and Measure Urinary NGAL to Measure Kidney Injury
Urinary NGAL,a biomarker for kidney injury was measured.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01440881
Brief Title
Does Nesiritide Provide Renal Protection
Official Title
Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
renal failure, cardiopulmonary bypass
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nesiritide
Arm Type
Active Comparator
Arm Description
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
infuses at 0.01MCG/KG/min for 48 hours
Intervention Type
Drug
Intervention Name(s)
Nesiritide
Other Intervention Name(s)
kidney protection post cardiopulmonary bypass.
Intervention Description
infuses at 0.01MCG/KG/min for 48 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
kidney protection post cardiopulmonary bypass
Intervention Description
infuses at 0.01MCG/KG/min for 48 hours
Primary Outcome Measure Information:
Title
Measure Neutrophils to Measure Kidney Injury
Description
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
Title
The Examine and Measure Cytokines to Measure Kidney Injury
Description
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
Title
The Examine and Measure Endothelin-1 to Measure Kidney Injury
Description
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
Title
The Examine and Measure Urinary NGAL to Measure Kidney Injury
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Beaver, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
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Does Nesiritide Provide Renal Protection
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