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Trial record 76 of 228 for:    EDN1

Does Nesiritide Provide Renal Protection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01440881
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : March 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Renal Failure
Interventions Drug: Nesiritide
Drug: Placebo
Enrollment 37
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 Details 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
Hide 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
Reason Not Completed
Death             0             1
Arm/Group Title Nesiritide Placebo Total
Hide 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 Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  28.6%
9
  60.0%
13
  44.8%
>=65 years
10
  71.4%
6
  40.0%
16
  55.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
5
  35.7%
5
  33.3%
10
  34.5%
Male
9
  64.3%
10
  66.7%
19
  65.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
14 15 29
1.Primary Outcome
Title Measure Neutrophils to Measure Kidney Injury
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nesiritide Placebo
Hide 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

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: log2 expression
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
randomized per protocol
Arm/Group Title Nesiritide Placebo
Hide 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
Overall Number of Participants Analyzed 14 15
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
IL-6 baseline
1.750
(0.407 to 7.189)
1.959
(0.433 to 9.273)
IL-6 time point 0
28.167
(18.008 to 40.283)
63.930
(49.471 to 99.201)
IL-6 1 hour post bypass
33.457
(24.237 to 48.103)
57.412
(40.169 to 120.589)
IL-6 2 hour post bypass
44.383
(35.629 to 62.855)
43.523
(35.380 to 118.481)
IL-6 4hour post bypass
35.759
(30.562 to 72.392)
37.967
(27.729 to 78.084)
IL-6 6 hour post bypass
28.593
(24.190 to 52.719)
27.840
(19.707 to 56.711)
IL-6 8 hours post bypass
29.794
(21.559 to 46.560)
21.673
(14.773 to 44.934)
IL-6 24 hours post bypas
29.513
(20.704 to 35.399)
34.650
(24.828 to 41.952)
IL8 baseline
5.377
(3.554 to 10.042)
5.238
(2.621 to 9.596)
IL-8 0 time point
16.821
(13.256 to 31.274)
18.962
(13.751 to 35.247)
IL8- 1 hour post bypass
17.107
(14.959 to 23.696)
20.873
(14.384 to 42.450)
IL8-2 hour post bypass
17.068
(15.574 to 34.241)
23.607
(14.957 to 36.670)
IL8 4 hour post bypass
16.005
(14.241 to 23.305)
17.627
(15.373 to 26.853)
IL8 6 hour post bypass
14.290
(12.090 to 23.910)
19.880
(12.237 to 24.394)
IL8 8hour post bypass
14.550
(11.221 to 19.530)
16.282
(9.661 to 19.578)
IL8 24 hour post bypass
12.264
(9.647 to 16.549)
14.600
(10.591 to 16.596)
IL10 baseline
8.063
(2.930 to 23.735)
9.130
(8.056 to 14.720)
IL10 0 time point
1289.776
(665.231 to 1691.249)
2206.177
(1666.118 to 2748.541)
IL 10 1 hour post bypass
1558.903
(1169.255 to 2519.783)
2074.906
(1196.237 to 2482.497)
IL10 2 hour post bypass
667.765
(549.079 to 918.143)
844.352
(406.264 to 1097.627)
IL 10 4 hour post bypass
309.351
(213.114 to 450.841)
230.101
(134.756 to 470.378)
IL 10 6 hour post bypass
107.778
(81.076 to 231.203)
95.925
(81.336 to 262.041)
IL 10 8 hour post bypass
103.791
(70.919 to 174.660)
84.070
(65.525 to 93.980)
IL 10 24 hour post bypass
18.597
(10.610 to 29.888)
34.862
(23.830 to 44.290)
TNF alpha baseline
6.286
(4.961 to 7.346)
5.402
(3.009 to 8.012)
TNF alpha 0 time point
8.253
(6.526 to 9.649)
7.795
(5.688 to 11.360)
TNF alpha 1hour post bypass
10.729
(9.265 to 12.630)
13.310
(8.519 to 15.580)
TNF alpha 2 hour post bypass
9.855
(8.885 to 11.307)
11.729
(9.975 to 13.947)
TNF alpha 4 hour post bypass
8.843
(7.002 to 13.359)
9.291
(6.509 to 13.568)
TNF alpha 6 hour post bypass
7.185
(5.607 to 11.008)
7.953
(4.840 to 10.815)
TNF alpha 8 hour post bypass
5.175
(4.284 to 8.931)
5.212
(2.800 to 6.250)
TNF alpha 24 hour post bypass
4.620
(1.971 to 6.091)
4.525
(3.365 to 6.618)
TNF beta baseline
1.162
(0.000 to 7.714)
0.056
(0.000 to 1.623)
TNF beta 0 time point
1.110
(0.055 to 8.519)
0.000
(0.000 to 1.031)
TNF beta 1 hour post bypass
0.898
(0.000 to 8.648)
0.000
(0.000 to 0.338)
TNF beta 2 hour post bypass
1.302
(0.198 to 6.717)
0.406
(0.000 to 0.950)
TNF beta 4 hour post bypass
1.698
(0.518 to 5.051)
0.074
(0.000 to 0.706)
TNF beta 6 hour post bypass
1.234
(0.149 to 5.796)
0.219
(0.000 to 0.498)
TNF beta 8 hour post bypass
1.389
(0.198 to 4.883)
0.058
(0.000 to 1.199)
TNF beta 24 hour post bypass
0.309
(0.000 to 8.662)
0.404
(0.000 to 1.589)
VEGF baseline
102.054
(41.148 to 151.786)
44.971
(33.233 to 78.745)
VEGF 0 time point
70.647
(27.779 to 121.082)
35.773
(28.314 to 57.292)
VEGF 1 hour post bypass
89.814
(48.225 to 157.629)
48.928
(20.450 to 67.083)
VEGF 2 hour post bypass
91.881
(50.242 to 153.212)
41.695
(22.994 to 93.293)
VEGF 4 hour poswt bypass
88.005
(43.210 to 161.897)
30.529
(19.981 to 68.473)
VEGF 6 hour post bypass
83.581
(42.650 to 144.648)
26.226
(24.178 to 56.900)
VEGF 8 hour post bypass
84.494
(39.215 to 137.660)
36.577
(28.953 to 70.361)
VEGF 24 hour post bypass
76.771
(43.973 to 121.778)
64.660
(29.898 to 98.724)
MCP-1 baseline
174.848
(143.677 to 215.191)
182.708
(146.434 to 250.832)
MCP-1 0 timepoint
478.742
(381.513 to 650.308)
455.129
(315.690 to 678.396)
MCP-1 1 hour post bypass
483.095
(408.870 to 822.554)
572.955
(429.401 to 955.947)
MCP-1 2 hour post bypass
441.203
(318.854 to 709.902)
502.992
(429.098 to 912.456)
MCP-1 4 hour post bypass
265.736
(211.247 to 432.764)
325.249
(288.906 to 392.275)
MCP-1 6 hour post bypass
191.735
(168.518 to 310.851)
218.561
(195.837 to 311.979)
MCP-1 8 hour post bypass
180.749
(128.801 to 232.952)
177.527
(149.096 to 239.253)
MCP-1 24 hour post bypass
202.621
(159.322 to 236.815)
215.708
(162.058 to 247.327)
EGF baseline
47.564
(28.196 to 75.165)
39.794
(26.826 to 74.659)
EGF 0 timepoint
31.242
(14.718 to 69.982)
21.983
(15.145 to 47.203)
EGF 1 hour post bypass
35.745
(21.122 to 79.986)
19.395
(14.549 to 33.210)
EGF 2 hour post bypass
24.052
(17.339 to 56.405)
23.662
(12.757 to 29.182)
EGF 4 hour post bypass
29.841
(15.028 to 48.199)
19.141
(11.353 to 23.873)
EGF 6 hour post bypass
33.050
(15.711 to 44.114)
22.655
(15.988 to 28.370)
EGF 8 post bypass
27.022
(12.558 to 47.269)
26.093
(16.129 to 36.236)
EGF 24 hour post bypass
30.494
(13.189 to 63.895)
17.768
(15.228 to 54.487)
IL-1 alpha baseline
12.372
(4.209 to 26.931)
2.754
(0.938 to 17.260)
IL-1 alpha 0 time
41.216
(20.491 to 49.241)
31.597
(15.750 to 32.969)
IL-1 alpha 1 hour post bypass
26.101
(10.389 to 43.738)
21.069
(8.055 to 29.453)
IL-1 alpha 2 hour post bypass
22.122
(12.403 to 36.620)
17.803
(6.430 to 25.311)
IL-1 alpha 4 hour post bypass
18.137
(14.394 to 25.199)
10.732
(3.549 to 17.785)
IL-1 alpha 6 hour post bypass
15.148
(7.747 to 24.294)
5.745
(2.233 to 16.900)
IL-1 alpha 8 hour post bypass
9.334
(4.901 to 21.816)
5.376
(1.093 to 10.690)
IL-1 alpha 24 hour post bypass
2.974
(1.426 to 19.918)
1.389
(0.000 to 9.465)
IL-1Beta baseline
1.014
(0.000 to 2.938)
0.394
(0.000 to 1.227)
IL-1Beta 0 time point
0.775
(0.000 to 2.599)
0.492
(0.000 to 0.775)
IL-1Beta 1 hour post bypass
0.653
(0.015 to 3.005)
0.430
(0.000 to 1.252)
IL-1Beta 2 hour post bypass
1.311
(0.001 to 3.051)
0.450
(0.000 to 1.411)
IL-1Beta 4 hour post bypass
1.716
(0.155 to 2.256)
0.310
(0.000 to 1.349)
IL-1Beta 6 hour post bypass
1.119
(0.000 to 2.531)
0.366
(0.000 to 1.237)
IL-1Beta 8 hour post bypass
0.875
(0.000 to 2.022)
0.462
(0.000 to 0.946)
IL-1Beta 24 hour post bypass
0.000
(0.000 to 1.876)
0.170
(0.000 to 1.742)
IL-1RA baseline
26.419
(0.000 to 33.138)
0.000
(0.000 to 21.347)
IL-1RA 0 time point
41.945
(14.544 to 96.153)
53.721
(24.312 to 108.171)
IL-1RA 1 hour post bypass
68.792
(13.478 to 112.704)
71.444
(35.659 to 163.338)
IL-1RA 2 hour post bypass
98.089
(65.649 to 227.339)
237.080
(104.788 to 396.803)
IL-1RA 4 hour post bypass
105.861
(48.931 to 173.007)
152.630
(90.576 to 330.576)
IL-1RA 6 hour post bypass
67.705
(31.982 to 141.879)
75.226
(30.186 to 128.904)
IL-1RA 8 hour post bypass
45.097
(3.338 to 70.559)
27.442
(14.928 to 120.969)
IL-1RA 24 hour post bypass
21.181
(0.00 to 38.018)
15.765
(0.000 to 38.997)
IL-2 baseline
0.850
(0.027 to 3.993)
0.068
(0.000 to 1.008)
IL-2 0 timepoint
1.130
(0.126 to 3.741)
0.401
(0.000 to 1.189)
IL-2 1 hour post bypass
1.714
(0.069 to 3.466)
0.059
(0.000 to 1.352)
IL-2 2 hour post bypass
1.714
(0.430 to 4.723)
1.110
(0.054 to 2.040)
IL-2 4 hour post bypass
1.753
(0.685 to 3.601)
0.870
(0.086 to 1.939)
IL-2 6 hour post bypass
1.297
(0.215 to 3.952)
0.923
(0.045 to 1.433)
IL-2 8 hour post bypass
1.281
(0.198 to 2.792)
0.599
(0.030 to 1.271)
IL-2 24 hour post bypass
0.921
(0.000 to 2.495)
0.172
(0.000 to 1.039)
IL-3 baseline
0.093
(0.000 to 0.552)
0.000
(0.000 to 0.292)
IL-3 0 timepoint
0.185
(0.000 to 0.544)
0.000
(0.000 to 0.196)
IL-3 1 hour post bypass
0.000
(0.000 to 0.410)
0.000
(0.000 to 0.200)
IL-3 2 hour post bypass
0.000
(0.000 to 0.355)
0.000
(0.000 to 0.258)
IL-3 4 hour post bypass
0.000
(0.000 to 0.372)
0.000
(0.000 to 0.191)
IL_3 6 hour post bypass
0.061
(0.000 to 0.377)
0.000
(0.000 to 0.217)
IL-3 8 hour post bypass
0.061
(0.000 to 0.293)
0.000
(0.000 to 0.199)
IL_3 24 hour post bypass
0.073
(0.000 to 0.445)
0.000
(0.000 to 0.234)
IL-4 baseline
4.295
(0.717 to 19.395)
0.166
(0.000 to 2.459)
IL-4 0 timepoint
6.285
(0.084 to 10.721)
0.359
(0.000 to 1.944)
IL-4 1 hour post bypass
6.221
(1.321 to 12.502)
0.414
(0.000 to 2.437)
IL_4 2 hour post bypass
5.534
(3.030 to 10.564)
1.381
(0.139 to 3.258)
IL-4 4 hour post bypass
6.743
(1.647 to 10.309)
0.958
(0.000 to 3.584)
IL-4 6 hour post bypass
4.859
(2.256 to 8.644)
0.746
(0.000 to 2.877)
IL-4 8 hour post bypass
4.063
(1.329 to 7.170)
0.000
(0.000 to 2.378)
IL_4 24 hour post bypass
3.634
(0.000 to 8.419)
0.000
(0.000 to 1.864)
IL-5 baseline
0.563
(0.000 to 4.234)
0.353
(0.000 to 1.233)
IL-5 0 timepoint
0.134
(0.000 to 0.808)
0.016
(0.000 to 0.580)
IL-5 1 hour post bypass
0.169
(0.000 to 1.145)
0.040
(0.000 to 0.789)
IL-5 2 hour post bypass
0.291
(0.000 to 0.901)
0.000
(0.000 to 1.104)
IL-5 4 hour post bypass
0.626
(0.000 to 1.089)
0.016
(0.000 to 1.083)
IL-5 6 hour post bypass
0.334
(0.000 to 1.252)
0.210
(0.000 to 0.900)
IL-5 8 hour post bypass
0.387
(0.020 to 0.574)
0.431
(0.000 to 0.796)
IL-5 24 hour post bypass
0.373
(0.000 to 1.366)
0.503
(0.055 to 0.794)
IL-7 baseline
4.032
(3.525 to 4.584)
2.987
(1.617 to 3.672)
IL-7 0 timepoint
3.673
(2.620 to 6.634)
4.311
(2.539 to 5.931)
IL-7 1 hour post bypass
2.973
(2.000 to 4.488)
1.822
(1.483 to 4.524)
IL-7 2 hour post bypass
2.469
(1.965 to 4.588)
2.104
(1.187 to 4.430)
IL-7 4 hour post bypass
3.061
(2.245 to 4.719)
2.530
(1.377 to 3.134)
IL-7 6 hour post bypass
3.391
(2.527 to 4.717)
2.317
(1.509 to 3.027)
IL-7 8 hour post bypass
3.506
(1.769 to 4.277)
2.354
(1.655 to 4.597)
IL-7 24 hour post bypass
3.656
(0.000 to 4.629)
4.097
(1.163 to 5.022)
IL-13 baseline
0.922
(0.000 to 11.185)
0.000
(0.000 to 2.027)
IL-13 0 timepoint
0.133
(0.000 to 4.913)
0.000
(0.000 to 0.302)
IL-13 1 hour post bypass
0.719
(0.000 to 5.817)
0.000
(0.000 to 0.989)
IL-13 2 hour post bypass
2.352
(0.000 to 4.561)
1.185
(0.000 to 1.794)
IL-13 4 hour post bypass
1.571
(0.000 to 3.443)
0.287
(0.000 to 1.029)
IL-13 6 hour post bypass
1.138
(0.000 to 5.160)
0.000
(0.000 to 0.746)
IL-13 8 hour post bypass
0.786
(0.000 to 2.603)
0.000
(0.000 to 0.573)
IL-13 24 hour post bypass
0.094
(0.000 to 5.222)
0.000
(0.000 to 1.233)
IL-15 baseline
1.905
(0.810 to 6.231)
0.969
(0.000 to 2.795)
IL-15 0 timepoint
3.200
(1.493 to 6.739)
3.093
(1.483 to 3.914)
IL-15 1 hour post bypass
4.228
(2.920 to 7.884)
3.981
(3.016 to 6.153)
IL-15 2 hour post bypass
5.556
(2.814 to 8.172)
4.641
(3.381 to 6.860)
IL-15 4 hour post bypass
5.723
(4.258 to 7.128)
4.423
(3.542 to 6.768)
IL-15 6 hour post bypass
5.021
(3.049 to 7.138)
4.395
(3.004 to 5.526)
IL-15 8 hour post bypass
4.984
(2.873 to 6.096)
3.316
(1.841 to 3.989)
IL-15 24 hour post bypass
6.120
(4.023 to 6.695)
4.996
(3.434 to 6.161)
IL-17 baseline
1.171
(0.000 to 2.730)
0.000
(0.000 to 2.552)
IL-17 0 time point
0.765
(0.000 to 4.558)
0.117
(0.000 to 0.943)
IL-17 1 hour post bypass
2.174
(0.202 to 7.780)
0.130
(0.000 to 0.768)
IL-17 2 hour post bypass
1.381
(0.475 to 7.394)
0.456
(0.000 to 1.228)
IL-17 4 hour post bypass
1.682
(0.412 to 3.982)
0.000
(0.000 to 1.899)
IL-17 6 hour post bypass
0.815
(0.196 to 3.582)
0.162
(0.000 to 1.290)
IL- 17 8 hour post bypass
0.817
(0.000 to 2.857)
0.000
(0.000 to 1.574)
IL-17 24 hour post bypass
0.397
(0.000 to 3.457)
0.0000
(0.000 to 2.480)
IP-10 baseline
506.657
(490.553 to 713.745)
475.656
(304.609 to 527.253)
IP-10 0 time point
2340.935
(1691.645 to 3585.567)
1790.035
(1554.647 to 3807.319)
IP-10 1 hour post bypass
1828.152
(1293.335 to 2297.526)
2298.747
(1478.354 to 2763.464)
IP-10 2 hour post bypass
1571.877
(1105.554 to 1991.710)
1365.169
(961.057 to 1998.178)
IP-10 4 hour post bypass
1072.023
(910.335 to 1338.142)
855.843
(608.726 to 1465.772)
IP-10 6 hour post bypass
704.208
(579.992 to 775.662)
575.429
(396.859 to 1059.186)
IP-10 8 hour post bypass
448.938
(292.341 to 570.529)
449.376
(295.222 to 675.398)
IP-10 24 hour post bypass
243.332
(213.669 to 265.925)
241.467
(157.583 to 333.628)
MIP-1 alpha baseline
2.251
(0.000 to 4.082)
0.000
(0.000 to 3.064)
MIP-1 alpha 0 time point
8.880
(5.954 to 11.191)
10.109
(4.705 to 14.815)
MIP-1 alpha 1 hour post bypass
9.042
(7.056 to 17.518)
9.182
(6.161 to 18.698)
MIP-1 alpha 2 hour post bypass
6.610
(5.410 to 8.129)
6.268
(4.309 to 10.444)
MIP-1 alpha 4 hour post bypass
4.024
(1.888 to 7.931)
4.309
(0.462 to 4.872)
MIP-1 alpha 6 hour post bypass
3.017
(0.154 to 6.573)
0.870
(0.000 to 2.779)
MIP-1 alpha 8 hour post bypass
1.933
(0.000 to 5.446)
0.000
(0.000 to 3.036)
MIP-1 alpha 24 hour post bypass
1.279
(0.000 to 2.870)
0.000
(0.000 to 1.806)
MIP-1 beta baseline
22.626
(19.968 to 33.454)
18.167
(14.254 to 23.434)
MIP-1 beta 0 time point
55.229
(41.784 to 105.270)
47.617
(35.620 to 55.731)
MIP-1 beta 1 hour post bypass
85.082
(60.080 to 159.731)
57.405
(48.300 to 71.806)
MIP-1 beta 2 hour post bypass
53.750
(38.134 to 86.942)
40.900
(34.678 to 48.173)
MIP-1 beta 4 hour post bypass
34.010
(24.951 to 44.472)
24.018
(22.720 to 28.116)
MIP-1 beta 6 hour post bypass
26.524
(21.681 to 52.531)
20.263
(17.094 to 25.972)
MIP-1 beta 8 hour post bypass
22.676
(17.226 to 37.256)
18.522
(16.173 to 24.292)
MIP-1 beta 24 hour post bypass
18.726
(15.327 to 23.802)
16.082
(12.354 to 20.734)
G-CSF baseline
50.953
(31.490 to 81.650)
43.984
(24.558 to 51.463)
G-CSF 0 time point
92.559
(66.615 to 120.739)
150.567
(117.980 to 180.159)
G-CSF 1 hour post bypass
124.298
(76.047 to 150.769)
253.527
(176.006 to 281.092)
G-CSF 2 hour post bypass
249.816
(176.392 to 280.874)
297.668
(206.217 to 439.136)
G-CSF 4 hour post bypass
285.277
(210.293 to 373.804)
311.452
(215.692 to 576.031)
G-CSF 6 hour post bypass
252.546
(193.625 to 305.081)
224.425
(197.557 to 382.366)
G-CSF 8 hour post bypass
264.061
(161.506 to 298.064)
243.292
(175.307 to 312.665)
G-CSF 24 hour post bypass
309.690
(161.764 to 385.424)
199.849
(128.946 to 286.537)
3.Primary Outcome
Title The Examine and Measure Endothelin-1 to Measure Kidney Injury
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
randomized as outlined in the protocol
Arm/Group Title Nesiritide Placebo
Hide 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
Overall Number of Participants Analyzed 14 15
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
baseline prior to infusion
1.778
(1.443 to 2.149)
1.239
(0.991 to 2.557)
time point 0
2.096
(1.899 to 2.568)
2.283
(1.924 to 3.077)
1 hour post bypass
1.670
(1.334 to 2.383)
2.068
(1.399 to 2.665)
2 hour post bypass
2.173
(1.898 to 2.507)
2.201
(1.591 to 2.915)
4 hour post bypass
2.395
(2.237 to 2.988)
3.116
(2.157 to 4.450)
6 hour post bypass
2.627
(2.320 to 3.317)
3.485
(2.421 to 4.633)
8 hour post bypass
2.744
(2.454 to 3.369)
3.143
(2.520 to 4.079)
24 hour post bypass
1.900
(1.550 to 2.901)
2.269
(1.688 to 3.541)
4.Primary Outcome
Title The Examine and Measure Urinary NGAL to Measure Kidney Injury
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
randomized as outlined in protocol
Arm/Group Title Nesiritide Placebo
Hide 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
Overall Number of Participants Analyzed 14 15
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
124.566
(29.819 to 340.163)
33.766
(9.825 to 425.434)
Time Frame June 2010 to December 2012
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nesiritide Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nesiritide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      3/15 (20.00%)    
Cardiac disorders     
Atrial Fibrillation  1 [1]  0/14 (0.00%)  0 1/15 (6.67%)  1
General disorders     
Syncope  1 [2]  0/14 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
Death  1 [3]  0/14 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
[1]
Subject was hospitalized for Atrial Fibrillation.
[2]
Subject went to the emergency room with a complaint of Syncope. Had surgery for an aortic valve replacement.
[3]
Patient expired from respiratory insufficiency and failure.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nesiritide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      1/15 (6.67%)    
Cardiac disorders     
Chest pain/ dysphagia  1 [1]  1/14 (7.14%)  1 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Shotness of breath  1 [2]  0/14 (0.00%)  0 1/15 (6.67%)  1
Surgical and medical procedures     
Mediastinal exploration with evacuation of mediastinal and right clots/blood  1 [3]  1/14 (7.14%)  1 0/15 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
[1]
substernal chest pain and dysphagia
[2]
post operative visit, admitted due to increased shortness of breath.
[3]
Mediastinal exploration with evacuation of mediastinal and right clots/blood
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
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas Beaver
Organization: University of Florida
Phone: 352-273-5501
EMail: thomas.beaver@surgery.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01440881     History of Changes
Other Study ID Numbers: 70-2010
09KW-03 ( Other Grant/Funding Number: Florida Department of Health )
First Submitted: February 10, 2011
First Posted: September 27, 2011
Results First Submitted: January 22, 2014
Results First Posted: March 6, 2014
Last Update Posted: June 6, 2014