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Does Nesiritide Provide Renal Protection

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT01440881
Collaborator
(none)
37
Enrollment
1
Location
2
Arms
32
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • kidney protection post cardiopulmonary bypass

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measure Neutrophils to Measure Kidney Injury [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Thomas Beaver, MD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT01440881
    Other Study ID Numbers:
    • 70-2010
    • 09KW-03
    First Posted:
    Sep 27, 2011
    Last Update Posted:
    Jun 6, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by University of Florida
    renal failure
    cardiopulmonary bypass
    Additional relevant MeSH terms:
    Renal Insufficiency
    Natriuretic Peptide, Brain

    Study Results

    Participant Flow

    Recruitment Details Starting in June 2010 and ending in December 2012, subjects were seen in outpatient clinics or in the hospital. The pre-operative labs were used to screen and enroll subjects.
    Pre-assignment Detail Out of the 37 signed informed consent there were 8 subjects who were consented and did not participate: 2 subjects changed their mind, 5 subjects creatinine level was not within the protocol level for participation, 1 subject surgery was canceled. This left 29 subjects to participate in the study.
    Arm/Group Title Nesiritide Placebo
    Arm/Group Description infuses at 0.01 micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours infuses at 0.01micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
    Period Title: Overall Study
    STARTED 14 15
    COMPLETED 14 14
    NOT COMPLETED 0 1

    Baseline Characteristics

    Arm/Group Title Nesiritide Placebo Total
    Arm/Group Description infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours Total of all reporting groups
    Overall Participants 14 15 29
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    4
    28.6%
    9
    60%
    13
    44.8%
    >=65 years
    10
    71.4%
    6
    40%
    16
    55.2%
    Sex: Female, Male (Count of Participants)
    Female
    5
    35.7%
    5
    33.3%
    10
    34.5%
    Male
    9
    64.3%
    10
    66.7%
    19
    65.5%
    Region of Enrollment (participants) [Number]
    United States
    14
    100%
    15
    100%
    29
    100%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Nesiritide Placebo
    Arm/Group Description infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
    Measure Participants 14 15
    Gene: TUFT1
    5.453
    (0.251)
    5.630
    (0.195)
    Gene: IL23A
    4.508
    (0.177)
    4.546
    (0.301)
    Gene: C6orf145
    5.501
    (0.216)
    5.444
    (0.156)
    Gene: HIST1H1C
    8.888
    (0.506)
    9.404
    (0.903)
    Gene: TBC1D26 /// ZNF286A
    4.990
    (0.092)
    4.930
    (0.113)
    Gene: RPL27
    9.269
    (0.191)
    9.315
    (0.214)
    Gene: LOC440087
    3.553
    (0.181)
    3.647
    (0.218)
    Gene: PRAMEF8
    5.828
    (0.232)
    5.856
    (0.233)
    Gene: RPL26
    7.440
    (0.205)
    7.481
    (0.212)
    Gene: OXT
    6.899
    (0.175)
    6.884
    (0.102)
    Gene: GIPC3
    6.158
    (0.124)
    6.097
    (0.114)
    Gene: ZNF540
    4.284
    (0.110)
    4.255
    (0.120)
    Gene: FAM98C
    6.778
    (0.146)
    6.857
    (0.129)
    Gene: PTOV1
    8.234
    (0.210)
    8.153
    (0.149)
    Gene: RPS16
    9.077
    (0.195)
    9.012
    (0.221)
    Gene: ERCC1
    5.798
    (0.171)
    5.843
    (0.242)
    Gene: LOC339344
    7.522
    (0.238)
    7.502
    (0.164)
    Gene: ATG10
    5.347
    (0.390)
    5.286
    (0.308)
    Gene: SLC35C1
    6.422
    (0.155)
    6.358
    (0.188)
    Gene: PTPMT1 /// NDUFS3 /// PTPMT1
    6.702
    (0.168)
    6.706
    (0.177)
    Gene: SIDT2
    6.792
    (0.215)
    6.870
    (0.161)
    Gene: Q6ZVY8_HUMAN
    5.229
    (0.124)
    5.132
    (0.214)
    Gene: CECR5
    5.519
    (0.108)
    5.499
    (0.105)
    Gene: VPS35
    9.042
    (0.339)
    8.974
    (0.379)
    Gene: LGALS2
    5.513
    (0.174)
    5.565
    (0.187)
    Gene: NDUFA6
    6.496
    (0.334)
    6.680
    (0.455)
    Gene: LOC497190 /// NP_001011880.1
    6.469
    (0.089)
    6.470
    (0.116)
    Gene: CXorf52
    6.151
    (0.480)
    6.301
    (0.387)
    Gene: MAP4K4
    10.656
    (0.121)
    10.651
    (0.159)
    Gene: LOC441241 /// VKORC1L1
    6.418
    (0.349)
    6.533
    (0.453)
    Gene: DBF4
    4.706
    (0.245)
    4.776
    (0.364)
    Gene: SP100
    9.074
    (0.242)
    9.205
    (0.191)
    Gene: TPT1
    9.177
    (0.139)
    9.242
    (0.125)
    Gene: LOC285908
    7.517
    (0.173)
    7.454
    (0.322)
    Gene: LOXHD1
    6.886
    (0.336)
    6.742
    (0.398)
    Gene: DYM
    8.158
    (0.241)
    8.088
    (0.281)
    Gene: Q6ZU44_HUMAN
    4.953
    (0.200)
    4.751
    (0.159)
    Gene: BAZ2B
    8.802
    (0.330)
    8.811
    (0.117)
    Gene: GRM8
    4.303
    (0.114)
    4.259
    (0.142)
    Gene: Q6ZP42_HUMAN
    4.967
    (0.251)
    5.040
    (0.336)
    Gene: HTR2B
    4.337
    (0.263)
    4.037
    (0.289)
    Gene: PRSS3
    6.338
    (0.123)
    6.241
    (0.118)
    Gene: LOC728449 /// ANXA8L2
    5.755
    (0.105)
    5.801
    (0.195)
    Gene: RPS24
    7.029
    (0.153)
    7.063
    (0.153)
    Gene: DOLPP1
    5.707
    (0.218)
    5.759
    (0.200)
    Gene: UBQLN1
    9.129
    (0.174)
    9.172
    (0.214)
    Gene: TNFSF15
    5.080
    (0.296)
    5.072
    (0.330)
    Gene: Q5QFB9_HUMAN
    4.770
    (0.456)
    4.430
    (0.427)
    Gene: CYP19A1
    3.696
    (0.126)
    3.725
    (0.131)
    Gene: Q6UWF5_HUMAN
    3.851
    (0.309)
    3.893
    (0.209)
    Gene: LOC340204 /// NP_001010886.1
    4.453
    (0.208)
    4.437
    (0.273)
    Gene: CCDC76
    3.702
    (0.211)
    3.627
    (0.211)
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    randomized per protocol
    Arm/Group Title Nesiritide Placebo
    Arm/Group Description infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
    Measure Participants 14 15
    IL-6 baseline
    1.750
    1.959
    IL-6 time point 0
    28.167
    63.930
    IL-6 1 hour post bypass
    33.457
    57.412
    IL-6 2 hour post bypass
    44.383
    43.523
    IL-6 4hour post bypass
    35.759
    37.967
    IL-6 6 hour post bypass
    28.593
    27.840
    IL-6 8 hours post bypass
    29.794
    21.673
    IL-6 24 hours post bypas
    29.513
    34.650
    IL8 baseline
    5.377
    5.238
    IL-8 0 time point
    16.821
    18.962
    IL8- 1 hour post bypass
    17.107
    20.873
    IL8-2 hour post bypass
    17.068
    23.607
    IL8 4 hour post bypass
    16.005
    17.627
    IL8 6 hour post bypass
    14.290
    19.880
    IL8 8hour post bypass
    14.550
    16.282
    IL8 24 hour post bypass
    12.264
    14.600
    IL10 baseline
    8.063
    9.130
    IL10 0 time point
    1289.776
    2206.177
    IL 10 1 hour post bypass
    1558.903
    2074.906
    IL10 2 hour post bypass
    667.765
    844.352
    IL 10 4 hour post bypass
    309.351
    230.101
    IL 10 6 hour post bypass
    107.778
    95.925
    IL 10 8 hour post bypass
    103.791
    84.070
    IL 10 24 hour post bypass
    18.597
    34.862
    TNF alpha baseline
    6.286
    5.402
    TNF alpha 0 time point
    8.253
    7.795
    TNF alpha 1hour post bypass
    10.729
    13.310
    TNF alpha 2 hour post bypass
    9.855
    11.729
    TNF alpha 4 hour post bypass
    8.843
    9.291
    TNF alpha 6 hour post bypass
    7.185
    7.953
    TNF alpha 8 hour post bypass
    5.175
    5.212
    TNF alpha 24 hour post bypass
    4.620
    4.525
    TNF beta baseline
    1.162
    0.056
    TNF beta 0 time point
    1.110
    0.000
    TNF beta 1 hour post bypass
    0.898
    0.000
    TNF beta 2 hour post bypass
    1.302
    0.406
    TNF beta 4 hour post bypass
    1.698
    0.074
    TNF beta 6 hour post bypass
    1.234
    0.219
    TNF beta 8 hour post bypass
    1.389
    0.058
    TNF beta 24 hour post bypass
    0.309
    0.404
    VEGF baseline
    102.054
    44.971
    VEGF 0 time point
    70.647
    35.773
    VEGF 1 hour post bypass
    89.814
    48.928
    VEGF 2 hour post bypass
    91.881
    41.695
    VEGF 4 hour poswt bypass
    88.005
    30.529
    VEGF 6 hour post bypass
    83.581
    26.226
    VEGF 8 hour post bypass
    84.494
    36.577
    VEGF 24 hour post bypass
    76.771
    64.660
    MCP-1 baseline
    174.848
    182.708
    MCP-1 0 timepoint
    478.742
    455.129
    MCP-1 1 hour post bypass
    483.095
    572.955
    MCP-1 2 hour post bypass
    441.203
    502.992
    MCP-1 4 hour post bypass
    265.736
    325.249
    MCP-1 6 hour post bypass
    191.735
    218.561
    MCP-1 8 hour post bypass
    180.749
    177.527
    MCP-1 24 hour post bypass
    202.621
    215.708
    EGF baseline
    47.564
    39.794
    EGF 0 timepoint
    31.242
    21.983
    EGF 1 hour post bypass
    35.745
    19.395
    EGF 2 hour post bypass
    24.052
    23.662
    EGF 4 hour post bypass
    29.841
    19.141
    EGF 6 hour post bypass
    33.050
    22.655
    EGF 8 post bypass
    27.022
    26.093
    EGF 24 hour post bypass
    30.494
    17.768
    IL-1 alpha baseline
    12.372
    2.754
    IL-1 alpha 0 time
    41.216
    31.597
    IL-1 alpha 1 hour post bypass
    26.101
    21.069
    IL-1 alpha 2 hour post bypass
    22.122
    17.803
    IL-1 alpha 4 hour post bypass
    18.137
    10.732
    IL-1 alpha 6 hour post bypass
    15.148
    5.745
    IL-1 alpha 8 hour post bypass
    9.334
    5.376
    IL-1 alpha 24 hour post bypass
    2.974
    1.389
    IL-1Beta baseline
    1.014
    0.394
    IL-1Beta 0 time point
    0.775
    0.492
    IL-1Beta 1 hour post bypass
    0.653
    0.430
    IL-1Beta 2 hour post bypass
    1.311
    0.450
    IL-1Beta 4 hour post bypass
    1.716
    0.310
    IL-1Beta 6 hour post bypass
    1.119
    0.366
    IL-1Beta 8 hour post bypass
    0.875
    0.462
    IL-1Beta 24 hour post bypass
    0.000
    0.170
    IL-1RA baseline
    26.419
    0.000
    IL-1RA 0 time point
    41.945
    53.721
    IL-1RA 1 hour post bypass
    68.792
    71.444
    IL-1RA 2 hour post bypass
    98.089
    237.080
    IL-1RA 4 hour post bypass
    105.861
    152.630
    IL-1RA 6 hour post bypass
    67.705
    75.226
    IL-1RA 8 hour post bypass
    45.097
    27.442
    IL-1RA 24 hour post bypass
    21.181
    15.765
    IL-2 baseline
    0.850
    0.068
    IL-2 0 timepoint
    1.130
    0.401
    IL-2 1 hour post bypass
    1.714
    0.059
    IL-2 2 hour post bypass
    1.714
    1.110
    IL-2 4 hour post bypass
    1.753
    0.870
    IL-2 6 hour post bypass
    1.297
    0.923
    IL-2 8 hour post bypass
    1.281
    0.599
    IL-2 24 hour post bypass
    0.921
    0.172
    IL-3 baseline
    0.093
    0.000
    IL-3 0 timepoint
    0.185
    0.000
    IL-3 1 hour post bypass
    0.000
    0.000
    IL-3 2 hour post bypass
    0.000
    0.000
    IL-3 4 hour post bypass
    0.000
    0.000
    IL_3 6 hour post bypass
    0.061
    0.000
    IL-3 8 hour post bypass
    0.061
    0.000
    IL_3 24 hour post bypass
    0.073
    0.000
    IL-4 baseline
    4.295
    0.166
    IL-4 0 timepoint
    6.285
    0.359
    IL-4 1 hour post bypass
    6.221
    0.414
    IL_4 2 hour post bypass
    5.534
    1.381
    IL-4 4 hour post bypass
    6.743
    0.958
    IL-4 6 hour post bypass
    4.859
    0.746
    IL-4 8 hour post bypass
    4.063
    0.000
    IL_4 24 hour post bypass
    3.634
    0.000
    IL-5 baseline
    0.563
    0.353
    IL-5 0 timepoint
    0.134
    0.016
    IL-5 1 hour post bypass
    0.169
    0.040
    IL-5 2 hour post bypass
    0.291
    0.000
    IL-5 4 hour post bypass
    0.626
    0.016
    IL-5 6 hour post bypass
    0.334
    0.210
    IL-5 8 hour post bypass
    0.387
    0.431
    IL-5 24 hour post bypass
    0.373
    0.503
    IL-7 baseline
    4.032
    2.987
    IL-7 0 timepoint
    3.673
    4.311
    IL-7 1 hour post bypass
    2.973
    1.822
    IL-7 2 hour post bypass
    2.469
    2.104
    IL-7 4 hour post bypass
    3.061
    2.530
    IL-7 6 hour post bypass
    3.391
    2.317
    IL-7 8 hour post bypass
    3.506
    2.354
    IL-7 24 hour post bypass
    3.656
    4.097
    IL-13 baseline
    0.922
    0.000
    IL-13 0 timepoint
    0.133
    0.000
    IL-13 1 hour post bypass
    0.719
    0.000
    IL-13 2 hour post bypass
    2.352
    1.185
    IL-13 4 hour post bypass
    1.571
    0.287
    IL-13 6 hour post bypass
    1.138
    0.000
    IL-13 8 hour post bypass
    0.786
    0.000
    IL-13 24 hour post bypass
    0.094
    0.000
    IL-15 baseline
    1.905
    0.969
    IL-15 0 timepoint
    3.200
    3.093
    IL-15 1 hour post bypass
    4.228
    3.981
    IL-15 2 hour post bypass
    5.556
    4.641
    IL-15 4 hour post bypass
    5.723
    4.423
    IL-15 6 hour post bypass
    5.021
    4.395
    IL-15 8 hour post bypass
    4.984
    3.316
    IL-15 24 hour post bypass
    6.120
    4.996
    IL-17 baseline
    1.171
    0.000
    IL-17 0 time point
    0.765
    0.117
    IL-17 1 hour post bypass
    2.174
    0.130
    IL-17 2 hour post bypass
    1.381
    0.456
    IL-17 4 hour post bypass
    1.682
    0.000
    IL-17 6 hour post bypass
    0.815
    0.162
    IL- 17 8 hour post bypass
    0.817
    0.000
    IL-17 24 hour post bypass
    0.397
    0.0000
    IP-10 baseline
    506.657
    475.656
    IP-10 0 time point
    2340.935
    1790.035
    IP-10 1 hour post bypass
    1828.152
    2298.747
    IP-10 2 hour post bypass
    1571.877
    1365.169
    IP-10 4 hour post bypass
    1072.023
    855.843
    IP-10 6 hour post bypass
    704.208
    575.429
    IP-10 8 hour post bypass
    448.938
    449.376
    IP-10 24 hour post bypass
    243.332
    241.467
    MIP-1 alpha baseline
    2.251
    0.000
    MIP-1 alpha 0 time point
    8.880
    10.109
    MIP-1 alpha 1 hour post bypass
    9.042
    9.182
    MIP-1 alpha 2 hour post bypass
    6.610
    6.268
    MIP-1 alpha 4 hour post bypass
    4.024
    4.309
    MIP-1 alpha 6 hour post bypass
    3.017
    0.870
    MIP-1 alpha 8 hour post bypass
    1.933
    0.000
    MIP-1 alpha 24 hour post bypass
    1.279
    0.000
    MIP-1 beta baseline
    22.626
    18.167
    MIP-1 beta 0 time point
    55.229
    47.617
    MIP-1 beta 1 hour post bypass
    85.082
    57.405
    MIP-1 beta 2 hour post bypass
    53.750
    40.900
    MIP-1 beta 4 hour post bypass
    34.010
    24.018
    MIP-1 beta 6 hour post bypass
    26.524
    20.263
    MIP-1 beta 8 hour post bypass
    22.676
    18.522
    MIP-1 beta 24 hour post bypass
    18.726
    16.082
    G-CSF baseline
    50.953
    43.984
    G-CSF 0 time point
    92.559
    150.567
    G-CSF 1 hour post bypass
    124.298
    253.527
    G-CSF 2 hour post bypass
    249.816
    297.668
    G-CSF 4 hour post bypass
    285.277
    311.452
    G-CSF 6 hour post bypass
    252.546
    224.425
    G-CSF 8 hour post bypass
    264.061
    243.292
    G-CSF 24 hour post bypass
    309.690
    199.849
    3. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    randomized as outlined in the protocol
    Arm/Group Title Nesiritide Placebo
    Arm/Group Description infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
    Measure Participants 14 15
    baseline prior to infusion
    1.778
    1.239
    time point 0
    2.096
    2.283
    1 hour post bypass
    1.670
    2.068
    2 hour post bypass
    2.173
    2.201
    4 hour post bypass
    2.395
    3.116
    6 hour post bypass
    2.627
    3.485
    8 hour post bypass
    2.744
    3.143
    24 hour post bypass
    1.900
    2.269
    4. Primary Outcome
    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.

    Outcome Measure Data

    Analysis Population Description
    randomized as outlined in protocol
    Arm/Group Title Nesiritide Placebo
    Arm/Group Description infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
    Measure Participants 14 15
    Median (Inter-Quartile Range) [ng/ml]
    124.566
    33.766

    Adverse Events

    Time Frame June 2010 to December 2012
    Adverse Event Reporting Description
    Arm/Group Title Nesiritide Placebo
    Arm/Group Description infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
    All Cause Mortality
    Nesiritide Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Nesiritide Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/14 (0%) 3/15 (20%)
    Cardiac disorders
    Atrial Fibrillation 0/14 (0%) 0 1/15 (6.7%) 1
    General disorders
    Syncope 0/14 (0%) 0 1/15 (6.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Death 0/14 (0%) 0 1/15 (6.7%) 1
    Other (Not Including Serious) Adverse Events
    Nesiritide Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/14 (14.3%) 1/15 (6.7%)
    Cardiac disorders
    Chest pain/ dysphagia 1/14 (7.1%) 1 0/15 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Shotness of breath 0/14 (0%) 0 1/15 (6.7%) 1
    Surgical and medical procedures
    Mediastinal exploration with evacuation of mediastinal and right clots/blood 1/14 (7.1%) 1 0/15 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Thomas Beaver
    Organization University of Florida
    Phone 352-273-5501
    Email thomas.beaver@surgery.ufl.edu
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT01440881
    Other Study ID Numbers:
    • 70-2010
    • 09KW-03
    First Posted:
    Sep 27, 2011
    Last Update Posted:
    Jun 6, 2014
    Last Verified:
    May 1, 2014