Trial Outcomes & Findings for Does Nesiritide Provide Renal Protection (NCT NCT01440881)

NCT ID: NCT01440881

Last Updated: 2014-06-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

30 days from the start of infusion

Results posted on

2014-06-06

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
Nesiritide
infuses at 0.01 micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours
Placebo
infuses at 0.01micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
Overall Study
STARTED
14
15
Overall Study
COMPLETED
14
14
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Nesiritide
infuses at 0.01 micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours
Placebo
infuses at 0.01micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
Overall Study
Death
0
1

Baseline Characteristics

Does Nesiritide Provide Renal Protection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Nesiritide
n=14 Participants
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours
Placebo
n=15 Participants
infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
Total
n=29 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=99 Participants
9 Participants
n=107 Participants
13 Participants
n=206 Participants
Age, Categorical
>=65 years
10 Participants
n=99 Participants
6 Participants
n=107 Participants
16 Participants
n=206 Participants
Sex: Female, Male
Female
5 Participants
n=99 Participants
5 Participants
n=107 Participants
10 Participants
n=206 Participants
Sex: Female, Male
Male
9 Participants
n=99 Participants
10 Participants
n=107 Participants
19 Participants
n=206 Participants
Region of Enrollment
United States
14 participants
n=99 Participants
15 participants
n=107 Participants
29 participants
n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Nesiritide
n=14 Participants
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours
Placebo
n=15 Participants
infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
Measure Neutrophils to Measure Kidney Injury
Gene: LOXHD1
6.886 log2 expression
Standard Deviation 0.336
6.742 log2 expression
Standard Deviation 0.398
Measure Neutrophils to Measure Kidney Injury
Gene: DYM
8.158 log2 expression
Standard Deviation 0.241
8.088 log2 expression
Standard Deviation 0.281
Measure Neutrophils to Measure Kidney Injury
Gene: Q6ZU44_HUMAN
4.953 log2 expression
Standard Deviation 0.200
4.751 log2 expression
Standard Deviation 0.159
Measure Neutrophils to Measure Kidney Injury
Gene: TUFT1
5.453 log2 expression
Standard Deviation 0.251
5.630 log2 expression
Standard Deviation 0.195
Measure Neutrophils to Measure Kidney Injury
Gene: IL23A
4.508 log2 expression
Standard Deviation 0.177
4.546 log2 expression
Standard Deviation 0.301
Measure Neutrophils to Measure Kidney Injury
Gene: C6orf145
5.501 log2 expression
Standard Deviation 0.216
5.444 log2 expression
Standard Deviation 0.156
Measure Neutrophils to Measure Kidney Injury
Gene: HIST1H1C
8.888 log2 expression
Standard Deviation 0.506
9.404 log2 expression
Standard Deviation 0.903
Measure Neutrophils to Measure Kidney Injury
Gene: TBC1D26 /// ZNF286A
4.990 log2 expression
Standard Deviation 0.092
4.930 log2 expression
Standard Deviation 0.113
Measure Neutrophils to Measure Kidney Injury
Gene: RPL27
9.269 log2 expression
Standard Deviation 0.191
9.315 log2 expression
Standard Deviation 0.214
Measure Neutrophils to Measure Kidney Injury
Gene: LOC440087
3.553 log2 expression
Standard Deviation 0.181
3.647 log2 expression
Standard Deviation 0.218
Measure Neutrophils to Measure Kidney Injury
Gene: PRAMEF8
5.828 log2 expression
Standard Deviation 0.232
5.856 log2 expression
Standard Deviation 0.233
Measure Neutrophils to Measure Kidney Injury
Gene: RPL26
7.440 log2 expression
Standard Deviation 0.205
7.481 log2 expression
Standard Deviation 0.212
Measure Neutrophils to Measure Kidney Injury
Gene: OXT
6.899 log2 expression
Standard Deviation 0.175
6.884 log2 expression
Standard Deviation 0.102
Measure Neutrophils to Measure Kidney Injury
Gene: GIPC3
6.158 log2 expression
Standard Deviation 0.124
6.097 log2 expression
Standard Deviation 0.114
Measure Neutrophils to Measure Kidney Injury
Gene: ZNF540
4.284 log2 expression
Standard Deviation 0.110
4.255 log2 expression
Standard Deviation 0.120
Measure Neutrophils to Measure Kidney Injury
Gene: FAM98C
6.778 log2 expression
Standard Deviation 0.146
6.857 log2 expression
Standard Deviation 0.129
Measure Neutrophils to Measure Kidney Injury
Gene: PTOV1
8.234 log2 expression
Standard Deviation 0.210
8.153 log2 expression
Standard Deviation 0.149
Measure Neutrophils to Measure Kidney Injury
Gene: RPS16
9.077 log2 expression
Standard Deviation 0.195
9.012 log2 expression
Standard Deviation 0.221
Measure Neutrophils to Measure Kidney Injury
Gene: ERCC1
5.798 log2 expression
Standard Deviation 0.171
5.843 log2 expression
Standard Deviation 0.242
Measure Neutrophils to Measure Kidney Injury
Gene: LOC339344
7.522 log2 expression
Standard Deviation 0.238
7.502 log2 expression
Standard Deviation 0.164
Measure Neutrophils to Measure Kidney Injury
Gene: ATG10
5.347 log2 expression
Standard Deviation 0.390
5.286 log2 expression
Standard Deviation 0.308
Measure Neutrophils to Measure Kidney Injury
Gene: SLC35C1
6.422 log2 expression
Standard Deviation 0.155
6.358 log2 expression
Standard Deviation 0.188
Measure Neutrophils to Measure Kidney Injury
Gene: PTPMT1 /// NDUFS3 /// PTPMT1
6.702 log2 expression
Standard Deviation 0.168
6.706 log2 expression
Standard Deviation 0.177
Measure Neutrophils to Measure Kidney Injury
Gene: SIDT2
6.792 log2 expression
Standard Deviation 0.215
6.870 log2 expression
Standard Deviation 0.161
Measure Neutrophils to Measure Kidney Injury
Gene: Q6ZVY8_HUMAN
5.229 log2 expression
Standard Deviation 0.124
5.132 log2 expression
Standard Deviation 0.214
Measure Neutrophils to Measure Kidney Injury
Gene: CECR5
5.519 log2 expression
Standard Deviation 0.108
5.499 log2 expression
Standard Deviation 0.105
Measure Neutrophils to Measure Kidney Injury
Gene: VPS35
9.042 log2 expression
Standard Deviation 0.339
8.974 log2 expression
Standard Deviation 0.379
Measure Neutrophils to Measure Kidney Injury
Gene: LGALS2
5.513 log2 expression
Standard Deviation 0.174
5.565 log2 expression
Standard Deviation 0.187
Measure Neutrophils to Measure Kidney Injury
Gene: NDUFA6
6.496 log2 expression
Standard Deviation 0.334
6.680 log2 expression
Standard Deviation 0.455
Measure Neutrophils to Measure Kidney Injury
Gene: LOC497190 /// NP_001011880.1
6.469 log2 expression
Standard Deviation 0.089
6.470 log2 expression
Standard Deviation 0.116
Measure Neutrophils to Measure Kidney Injury
Gene: CXorf52
6.151 log2 expression
Standard Deviation 0.480
6.301 log2 expression
Standard Deviation 0.387
Measure Neutrophils to Measure Kidney Injury
Gene: MAP4K4
10.656 log2 expression
Standard Deviation 0.121
10.651 log2 expression
Standard Deviation 0.159
Measure Neutrophils to Measure Kidney Injury
Gene: LOC441241 /// VKORC1L1
6.418 log2 expression
Standard Deviation 0.349
6.533 log2 expression
Standard Deviation 0.453
Measure Neutrophils to Measure Kidney Injury
Gene: DBF4
4.706 log2 expression
Standard Deviation 0.245
4.776 log2 expression
Standard Deviation 0.364
Measure Neutrophils to Measure Kidney Injury
Gene: SP100
9.074 log2 expression
Standard Deviation 0.242
9.205 log2 expression
Standard Deviation 0.191
Measure Neutrophils to Measure Kidney Injury
Gene: TPT1
9.177 log2 expression
Standard Deviation 0.139
9.242 log2 expression
Standard Deviation 0.125
Measure Neutrophils to Measure Kidney Injury
Gene: LOC285908
7.517 log2 expression
Standard Deviation 0.173
7.454 log2 expression
Standard Deviation 0.322
Measure Neutrophils to Measure Kidney Injury
Gene: BAZ2B
8.802 log2 expression
Standard Deviation 0.330
8.811 log2 expression
Standard Deviation 0.117
Measure Neutrophils to Measure Kidney Injury
Gene: GRM8
4.303 log2 expression
Standard Deviation 0.114
4.259 log2 expression
Standard Deviation 0.142
Measure Neutrophils to Measure Kidney Injury
Gene: Q6ZP42_HUMAN
4.967 log2 expression
Standard Deviation 0.251
5.040 log2 expression
Standard Deviation 0.336
Measure Neutrophils to Measure Kidney Injury
Gene: HTR2B
4.337 log2 expression
Standard Deviation 0.263
4.037 log2 expression
Standard Deviation 0.289
Measure Neutrophils to Measure Kidney Injury
Gene: PRSS3
6.338 log2 expression
Standard Deviation 0.123
6.241 log2 expression
Standard Deviation 0.118
Measure Neutrophils to Measure Kidney Injury
Gene: LOC728449 /// ANXA8L2
5.755 log2 expression
Standard Deviation 0.105
5.801 log2 expression
Standard Deviation 0.195
Measure Neutrophils to Measure Kidney Injury
Gene: RPS24
7.029 log2 expression
Standard Deviation 0.153
7.063 log2 expression
Standard Deviation 0.153
Measure Neutrophils to Measure Kidney Injury
Gene: DOLPP1
5.707 log2 expression
Standard Deviation 0.218
5.759 log2 expression
Standard Deviation 0.200
Measure Neutrophils to Measure Kidney Injury
Gene: UBQLN1
9.129 log2 expression
Standard Deviation 0.174
9.172 log2 expression
Standard Deviation 0.214
Measure Neutrophils to Measure Kidney Injury
Gene: TNFSF15
5.080 log2 expression
Standard Deviation 0.296
5.072 log2 expression
Standard Deviation 0.330
Measure Neutrophils to Measure Kidney Injury
Gene: Q5QFB9_HUMAN
4.770 log2 expression
Standard Deviation 0.456
4.430 log2 expression
Standard Deviation 0.427
Measure Neutrophils to Measure Kidney Injury
Gene: CYP19A1
3.696 log2 expression
Standard Deviation 0.126
3.725 log2 expression
Standard Deviation 0.131
Measure Neutrophils to Measure Kidney Injury
Gene: Q6UWF5_HUMAN
3.851 log2 expression
Standard Deviation 0.309
3.893 log2 expression
Standard Deviation 0.209
Measure Neutrophils to Measure Kidney Injury
Gene: LOC340204 /// NP_001010886.1
4.453 log2 expression
Standard Deviation 0.208
4.437 log2 expression
Standard Deviation 0.273
Measure Neutrophils to Measure Kidney Injury
Gene: CCDC76
3.702 log2 expression
Standard Deviation 0.211
3.627 log2 expression
Standard Deviation 0.211

PRIMARY outcome

Timeframe: 30 days from the start of infusion

Population: randomized per protocol

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

Outcome measures

Outcome measures
Measure
Nesiritide
n=14 Participants
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours
Placebo
n=15 Participants
infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
The Examine and Measure Cytokines to Measure Kidney Injury
IL-6 baseline
1.750 pg/ml
Interval 0.407 to 7.189
1.959 pg/ml
Interval 0.433 to 9.273
The Examine and Measure Cytokines to Measure Kidney Injury
IL-6 time point 0
28.167 pg/ml
Interval 18.008 to 40.283
63.930 pg/ml
Interval 49.471 to 99.201
The Examine and Measure Cytokines to Measure Kidney Injury
IL-6 1 hour post bypass
33.457 pg/ml
Interval 24.237 to 48.103
57.412 pg/ml
Interval 40.169 to 120.589
The Examine and Measure Cytokines to Measure Kidney Injury
IL-6 2 hour post bypass
44.383 pg/ml
Interval 35.629 to 62.855
43.523 pg/ml
Interval 35.38 to 118.481
The Examine and Measure Cytokines to Measure Kidney Injury
IL-6 4hour post bypass
35.759 pg/ml
Interval 30.562 to 72.392
37.967 pg/ml
Interval 27.729 to 78.084
The Examine and Measure Cytokines to Measure Kidney Injury
IL-6 6 hour post bypass
28.593 pg/ml
Interval 24.19 to 52.719
27.840 pg/ml
Interval 19.707 to 56.711
The Examine and Measure Cytokines to Measure Kidney Injury
IL-6 8 hours post bypass
29.794 pg/ml
Interval 21.559 to 46.56
21.673 pg/ml
Interval 14.773 to 44.934
The Examine and Measure Cytokines to Measure Kidney Injury
IL-6 24 hours post bypas
29.513 pg/ml
Interval 20.704 to 35.399
34.650 pg/ml
Interval 24.828 to 41.952
The Examine and Measure Cytokines to Measure Kidney Injury
IL8 baseline
5.377 pg/ml
Interval 3.554 to 10.042
5.238 pg/ml
Interval 2.621 to 9.596
The Examine and Measure Cytokines to Measure Kidney Injury
IL-8 0 time point
16.821 pg/ml
Interval 13.256 to 31.274
18.962 pg/ml
Interval 13.751 to 35.247
The Examine and Measure Cytokines to Measure Kidney Injury
IL8- 1 hour post bypass
17.107 pg/ml
Interval 14.959 to 23.696
20.873 pg/ml
Interval 14.384 to 42.45
The Examine and Measure Cytokines to Measure Kidney Injury
IL8-2 hour post bypass
17.068 pg/ml
Interval 15.574 to 34.241
23.607 pg/ml
Interval 14.957 to 36.67
The Examine and Measure Cytokines to Measure Kidney Injury
IL8 4 hour post bypass
16.005 pg/ml
Interval 14.241 to 23.305
17.627 pg/ml
Interval 15.373 to 26.853
The Examine and Measure Cytokines to Measure Kidney Injury
IL8 6 hour post bypass
14.290 pg/ml
Interval 12.09 to 23.91
19.880 pg/ml
Interval 12.237 to 24.394
The Examine and Measure Cytokines to Measure Kidney Injury
IL8 8hour post bypass
14.550 pg/ml
Interval 11.221 to 19.53
16.282 pg/ml
Interval 9.661 to 19.578
The Examine and Measure Cytokines to Measure Kidney Injury
IL8 24 hour post bypass
12.264 pg/ml
Interval 9.647 to 16.549
14.600 pg/ml
Interval 10.591 to 16.596
The Examine and Measure Cytokines to Measure Kidney Injury
IL10 baseline
8.063 pg/ml
Interval 2.93 to 23.735
9.130 pg/ml
Interval 8.056 to 14.72
The Examine and Measure Cytokines to Measure Kidney Injury
IL10 0 time point
1289.776 pg/ml
Interval 665.231 to 1691.249
2206.177 pg/ml
Interval 1666.118 to 2748.541
The Examine and Measure Cytokines to Measure Kidney Injury
IL 10 1 hour post bypass
1558.903 pg/ml
Interval 1169.255 to 2519.783
2074.906 pg/ml
Interval 1196.237 to 2482.497
The Examine and Measure Cytokines to Measure Kidney Injury
IL10 2 hour post bypass
667.765 pg/ml
Interval 549.079 to 918.143
844.352 pg/ml
Interval 406.264 to 1097.627
The Examine and Measure Cytokines to Measure Kidney Injury
IL 10 4 hour post bypass
309.351 pg/ml
Interval 213.114 to 450.841
230.101 pg/ml
Interval 134.756 to 470.378
The Examine and Measure Cytokines to Measure Kidney Injury
IL 10 6 hour post bypass
107.778 pg/ml
Interval 81.076 to 231.203
95.925 pg/ml
Interval 81.336 to 262.041
The Examine and Measure Cytokines to Measure Kidney Injury
IL 10 8 hour post bypass
103.791 pg/ml
Interval 70.919 to 174.66
84.070 pg/ml
Interval 65.525 to 93.98
The Examine and Measure Cytokines to Measure Kidney Injury
IL 10 24 hour post bypass
18.597 pg/ml
Interval 10.61 to 29.888
34.862 pg/ml
Interval 23.83 to 44.29
The Examine and Measure Cytokines to Measure Kidney Injury
TNF alpha baseline
6.286 pg/ml
Interval 4.961 to 7.346
5.402 pg/ml
Interval 3.009 to 8.012
The Examine and Measure Cytokines to Measure Kidney Injury
TNF alpha 0 time point
8.253 pg/ml
Interval 6.526 to 9.649
7.795 pg/ml
Interval 5.688 to 11.36
The Examine and Measure Cytokines to Measure Kidney Injury
TNF alpha 1hour post bypass
10.729 pg/ml
Interval 9.265 to 12.63
13.310 pg/ml
Interval 8.519 to 15.58
The Examine and Measure Cytokines to Measure Kidney Injury
TNF alpha 2 hour post bypass
9.855 pg/ml
Interval 8.885 to 11.307
11.729 pg/ml
Interval 9.975 to 13.947
The Examine and Measure Cytokines to Measure Kidney Injury
TNF alpha 4 hour post bypass
8.843 pg/ml
Interval 7.002 to 13.359
9.291 pg/ml
Interval 6.509 to 13.568
The Examine and Measure Cytokines to Measure Kidney Injury
TNF alpha 6 hour post bypass
7.185 pg/ml
Interval 5.607 to 11.008
7.953 pg/ml
Interval 4.84 to 10.815
The Examine and Measure Cytokines to Measure Kidney Injury
TNF alpha 8 hour post bypass
5.175 pg/ml
Interval 4.284 to 8.931
5.212 pg/ml
Interval 2.8 to 6.25
The Examine and Measure Cytokines to Measure Kidney Injury
TNF alpha 24 hour post bypass
4.620 pg/ml
Interval 1.971 to 6.091
4.525 pg/ml
Interval 3.365 to 6.618
The Examine and Measure Cytokines to Measure Kidney Injury
TNF beta baseline
1.162 pg/ml
Interval 0.0 to 7.714
0.056 pg/ml
Interval 0.0 to 1.623
The Examine and Measure Cytokines to Measure Kidney Injury
TNF beta 0 time point
1.110 pg/ml
Interval 0.055 to 8.519
0.000 pg/ml
Interval 0.0 to 1.031
The Examine and Measure Cytokines to Measure Kidney Injury
TNF beta 1 hour post bypass
0.898 pg/ml
Interval 0.0 to 8.648
0.000 pg/ml
Interval 0.0 to 0.338
The Examine and Measure Cytokines to Measure Kidney Injury
TNF beta 2 hour post bypass
1.302 pg/ml
Interval 0.198 to 6.717
0.406 pg/ml
Interval 0.0 to 0.95
The Examine and Measure Cytokines to Measure Kidney Injury
TNF beta 4 hour post bypass
1.698 pg/ml
Interval 0.518 to 5.051
0.074 pg/ml
Interval 0.0 to 0.706
The Examine and Measure Cytokines to Measure Kidney Injury
TNF beta 6 hour post bypass
1.234 pg/ml
Interval 0.149 to 5.796
0.219 pg/ml
Interval 0.0 to 0.498
The Examine and Measure Cytokines to Measure Kidney Injury
TNF beta 8 hour post bypass
1.389 pg/ml
Interval 0.198 to 4.883
0.058 pg/ml
Interval 0.0 to 1.199
The Examine and Measure Cytokines to Measure Kidney Injury
TNF beta 24 hour post bypass
0.309 pg/ml
Interval 0.0 to 8.662
0.404 pg/ml
Interval 0.0 to 1.589
The Examine and Measure Cytokines to Measure Kidney Injury
VEGF baseline
102.054 pg/ml
Interval 41.148 to 151.786
44.971 pg/ml
Interval 33.233 to 78.745
The Examine and Measure Cytokines to Measure Kidney Injury
VEGF 0 time point
70.647 pg/ml
Interval 27.779 to 121.082
35.773 pg/ml
Interval 28.314 to 57.292
The Examine and Measure Cytokines to Measure Kidney Injury
VEGF 1 hour post bypass
89.814 pg/ml
Interval 48.225 to 157.629
48.928 pg/ml
Interval 20.45 to 67.083
The Examine and Measure Cytokines to Measure Kidney Injury
VEGF 2 hour post bypass
91.881 pg/ml
Interval 50.242 to 153.212
41.695 pg/ml
Interval 22.994 to 93.293
The Examine and Measure Cytokines to Measure Kidney Injury
VEGF 4 hour poswt bypass
88.005 pg/ml
Interval 43.21 to 161.897
30.529 pg/ml
Interval 19.981 to 68.473
The Examine and Measure Cytokines to Measure Kidney Injury
VEGF 6 hour post bypass
83.581 pg/ml
Interval 42.65 to 144.648
26.226 pg/ml
Interval 24.178 to 56.9
The Examine and Measure Cytokines to Measure Kidney Injury
VEGF 8 hour post bypass
84.494 pg/ml
Interval 39.215 to 137.66
36.577 pg/ml
Interval 28.953 to 70.361
The Examine and Measure Cytokines to Measure Kidney Injury
VEGF 24 hour post bypass
76.771 pg/ml
Interval 43.973 to 121.778
64.660 pg/ml
Interval 29.898 to 98.724
The Examine and Measure Cytokines to Measure Kidney Injury
MCP-1 baseline
174.848 pg/ml
Interval 143.677 to 215.191
182.708 pg/ml
Interval 146.434 to 250.832
The Examine and Measure Cytokines to Measure Kidney Injury
MCP-1 0 timepoint
478.742 pg/ml
Interval 381.513 to 650.308
455.129 pg/ml
Interval 315.69 to 678.396
The Examine and Measure Cytokines to Measure Kidney Injury
MCP-1 1 hour post bypass
483.095 pg/ml
Interval 408.87 to 822.554
572.955 pg/ml
Interval 429.401 to 955.947
The Examine and Measure Cytokines to Measure Kidney Injury
MCP-1 2 hour post bypass
441.203 pg/ml
Interval 318.854 to 709.902
502.992 pg/ml
Interval 429.098 to 912.456
The Examine and Measure Cytokines to Measure Kidney Injury
MCP-1 4 hour post bypass
265.736 pg/ml
Interval 211.247 to 432.764
325.249 pg/ml
Interval 288.906 to 392.275
The Examine and Measure Cytokines to Measure Kidney Injury
MCP-1 6 hour post bypass
191.735 pg/ml
Interval 168.518 to 310.851
218.561 pg/ml
Interval 195.837 to 311.979
The Examine and Measure Cytokines to Measure Kidney Injury
MCP-1 8 hour post bypass
180.749 pg/ml
Interval 128.801 to 232.952
177.527 pg/ml
Interval 149.096 to 239.253
The Examine and Measure Cytokines to Measure Kidney Injury
MCP-1 24 hour post bypass
202.621 pg/ml
Interval 159.322 to 236.815
215.708 pg/ml
Interval 162.058 to 247.327
The Examine and Measure Cytokines to Measure Kidney Injury
EGF baseline
47.564 pg/ml
Interval 28.196 to 75.165
39.794 pg/ml
Interval 26.826 to 74.659
The Examine and Measure Cytokines to Measure Kidney Injury
EGF 0 timepoint
31.242 pg/ml
Interval 14.718 to 69.982
21.983 pg/ml
Interval 15.145 to 47.203
The Examine and Measure Cytokines to Measure Kidney Injury
EGF 1 hour post bypass
35.745 pg/ml
Interval 21.122 to 79.986
19.395 pg/ml
Interval 14.549 to 33.21
The Examine and Measure Cytokines to Measure Kidney Injury
EGF 2 hour post bypass
24.052 pg/ml
Interval 17.339 to 56.405
23.662 pg/ml
Interval 12.757 to 29.182
The Examine and Measure Cytokines to Measure Kidney Injury
EGF 4 hour post bypass
29.841 pg/ml
Interval 15.028 to 48.199
19.141 pg/ml
Interval 11.353 to 23.873
The Examine and Measure Cytokines to Measure Kidney Injury
EGF 6 hour post bypass
33.050 pg/ml
Interval 15.711 to 44.114
22.655 pg/ml
Interval 15.988 to 28.37
The Examine and Measure Cytokines to Measure Kidney Injury
EGF 8 post bypass
27.022 pg/ml
Interval 12.558 to 47.269
26.093 pg/ml
Interval 16.129 to 36.236
The Examine and Measure Cytokines to Measure Kidney Injury
EGF 24 hour post bypass
30.494 pg/ml
Interval 13.189 to 63.895
17.768 pg/ml
Interval 15.228 to 54.487
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1 alpha baseline
12.372 pg/ml
Interval 4.209 to 26.931
2.754 pg/ml
Interval 0.938 to 17.26
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1 alpha 0 time
41.216 pg/ml
Interval 20.491 to 49.241
31.597 pg/ml
Interval 15.75 to 32.969
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1 alpha 1 hour post bypass
26.101 pg/ml
Interval 10.389 to 43.738
21.069 pg/ml
Interval 8.055 to 29.453
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1 alpha 2 hour post bypass
22.122 pg/ml
Interval 12.403 to 36.62
17.803 pg/ml
Interval 6.43 to 25.311
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1 alpha 4 hour post bypass
18.137 pg/ml
Interval 14.394 to 25.199
10.732 pg/ml
Interval 3.549 to 17.785
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1 alpha 6 hour post bypass
15.148 pg/ml
Interval 7.747 to 24.294
5.745 pg/ml
Interval 2.233 to 16.9
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1 alpha 8 hour post bypass
9.334 pg/ml
Interval 4.901 to 21.816
5.376 pg/ml
Interval 1.093 to 10.69
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1 alpha 24 hour post bypass
2.974 pg/ml
Interval 1.426 to 19.918
1.389 pg/ml
Interval 0.0 to 9.465
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1Beta baseline
1.014 pg/ml
Interval 0.0 to 2.938
0.394 pg/ml
Interval 0.0 to 1.227
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1Beta 0 time point
0.775 pg/ml
Interval 0.0 to 2.599
0.492 pg/ml
Interval 0.0 to 0.775
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1Beta 1 hour post bypass
0.653 pg/ml
Interval 0.015 to 3.005
0.430 pg/ml
Interval 0.0 to 1.252
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1Beta 2 hour post bypass
1.311 pg/ml
Interval 0.001 to 3.051
0.450 pg/ml
Interval 0.0 to 1.411
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1Beta 4 hour post bypass
1.716 pg/ml
Interval 0.155 to 2.256
0.310 pg/ml
Interval 0.0 to 1.349
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1Beta 6 hour post bypass
1.119 pg/ml
Interval 0.0 to 2.531
0.366 pg/ml
Interval 0.0 to 1.237
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1Beta 8 hour post bypass
0.875 pg/ml
Interval 0.0 to 2.022
0.462 pg/ml
Interval 0.0 to 0.946
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1Beta 24 hour post bypass
0.000 pg/ml
Interval 0.0 to 1.876
0.170 pg/ml
Interval 0.0 to 1.742
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1RA baseline
26.419 pg/ml
Interval 0.0 to 33.138
0.000 pg/ml
Interval 0.0 to 21.347
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1RA 0 time point
41.945 pg/ml
Interval 14.544 to 96.153
53.721 pg/ml
Interval 24.312 to 108.171
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1RA 1 hour post bypass
68.792 pg/ml
Interval 13.478 to 112.704
71.444 pg/ml
Interval 35.659 to 163.338
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1RA 2 hour post bypass
98.089 pg/ml
Interval 65.649 to 227.339
237.080 pg/ml
Interval 104.788 to 396.803
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1RA 4 hour post bypass
105.861 pg/ml
Interval 48.931 to 173.007
152.630 pg/ml
Interval 90.576 to 330.576
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1RA 6 hour post bypass
67.705 pg/ml
Interval 31.982 to 141.879
75.226 pg/ml
Interval 30.186 to 128.904
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1RA 8 hour post bypass
45.097 pg/ml
Interval 3.338 to 70.559
27.442 pg/ml
Interval 14.928 to 120.969
The Examine and Measure Cytokines to Measure Kidney Injury
IL-1RA 24 hour post bypass
21.181 pg/ml
Interval 0.0 to 38.018
15.765 pg/ml
Interval 0.0 to 38.997
The Examine and Measure Cytokines to Measure Kidney Injury
IL-2 baseline
0.850 pg/ml
Interval 0.027 to 3.993
0.068 pg/ml
Interval 0.0 to 1.008
The Examine and Measure Cytokines to Measure Kidney Injury
IL-2 0 timepoint
1.130 pg/ml
Interval 0.126 to 3.741
0.401 pg/ml
Interval 0.0 to 1.189
The Examine and Measure Cytokines to Measure Kidney Injury
IL-2 1 hour post bypass
1.714 pg/ml
Interval 0.069 to 3.466
0.059 pg/ml
Interval 0.0 to 1.352
The Examine and Measure Cytokines to Measure Kidney Injury
IL-2 2 hour post bypass
1.714 pg/ml
Interval 0.43 to 4.723
1.110 pg/ml
Interval 0.054 to 2.04
The Examine and Measure Cytokines to Measure Kidney Injury
IL-2 4 hour post bypass
1.753 pg/ml
Interval 0.685 to 3.601
0.870 pg/ml
Interval 0.086 to 1.939
The Examine and Measure Cytokines to Measure Kidney Injury
IL-2 6 hour post bypass
1.297 pg/ml
Interval 0.215 to 3.952
0.923 pg/ml
Interval 0.045 to 1.433
The Examine and Measure Cytokines to Measure Kidney Injury
IL-2 8 hour post bypass
1.281 pg/ml
Interval 0.198 to 2.792
0.599 pg/ml
Interval 0.03 to 1.271
The Examine and Measure Cytokines to Measure Kidney Injury
IL-2 24 hour post bypass
0.921 pg/ml
Interval 0.0 to 2.495
0.172 pg/ml
Interval 0.0 to 1.039
The Examine and Measure Cytokines to Measure Kidney Injury
IL-3 baseline
0.093 pg/ml
Interval 0.0 to 0.552
0.000 pg/ml
Interval 0.0 to 0.292
The Examine and Measure Cytokines to Measure Kidney Injury
IL-3 0 timepoint
0.185 pg/ml
Interval 0.0 to 0.544
0.000 pg/ml
Interval 0.0 to 0.196
The Examine and Measure Cytokines to Measure Kidney Injury
IL-3 1 hour post bypass
0.000 pg/ml
Interval 0.0 to 0.41
0.000 pg/ml
Interval 0.0 to 0.2
The Examine and Measure Cytokines to Measure Kidney Injury
IL-3 2 hour post bypass
0.000 pg/ml
Interval 0.0 to 0.355
0.000 pg/ml
Interval 0.0 to 0.258
The Examine and Measure Cytokines to Measure Kidney Injury
IL-3 4 hour post bypass
0.000 pg/ml
Interval 0.0 to 0.372
0.000 pg/ml
Interval 0.0 to 0.191
The Examine and Measure Cytokines to Measure Kidney Injury
IL_3 6 hour post bypass
0.061 pg/ml
Interval 0.0 to 0.377
0.000 pg/ml
Interval 0.0 to 0.217
The Examine and Measure Cytokines to Measure Kidney Injury
IL-3 8 hour post bypass
0.061 pg/ml
Interval 0.0 to 0.293
0.000 pg/ml
Interval 0.0 to 0.199
The Examine and Measure Cytokines to Measure Kidney Injury
IL_3 24 hour post bypass
0.073 pg/ml
Interval 0.0 to 0.445
0.000 pg/ml
Interval 0.0 to 0.234
The Examine and Measure Cytokines to Measure Kidney Injury
IL-4 baseline
4.295 pg/ml
Interval 0.717 to 19.395
0.166 pg/ml
Interval 0.0 to 2.459
The Examine and Measure Cytokines to Measure Kidney Injury
IL-4 0 timepoint
6.285 pg/ml
Interval 0.084 to 10.721
0.359 pg/ml
Interval 0.0 to 1.944
The Examine and Measure Cytokines to Measure Kidney Injury
IL-4 1 hour post bypass
6.221 pg/ml
Interval 1.321 to 12.502
0.414 pg/ml
Interval 0.0 to 2.437
The Examine and Measure Cytokines to Measure Kidney Injury
IL_4 2 hour post bypass
5.534 pg/ml
Interval 3.03 to 10.564
1.381 pg/ml
Interval 0.139 to 3.258
The Examine and Measure Cytokines to Measure Kidney Injury
IL-4 4 hour post bypass
6.743 pg/ml
Interval 1.647 to 10.309
0.958 pg/ml
Interval 0.0 to 3.584
The Examine and Measure Cytokines to Measure Kidney Injury
IL-4 6 hour post bypass
4.859 pg/ml
Interval 2.256 to 8.644
0.746 pg/ml
Interval 0.0 to 2.877
The Examine and Measure Cytokines to Measure Kidney Injury
IL-4 8 hour post bypass
4.063 pg/ml
Interval 1.329 to 7.17
0.000 pg/ml
Interval 0.0 to 2.378
The Examine and Measure Cytokines to Measure Kidney Injury
IL_4 24 hour post bypass
3.634 pg/ml
Interval 0.0 to 8.419
0.000 pg/ml
Interval 0.0 to 1.864
The Examine and Measure Cytokines to Measure Kidney Injury
IL-5 baseline
0.563 pg/ml
Interval 0.0 to 4.234
0.353 pg/ml
Interval 0.0 to 1.233
The Examine and Measure Cytokines to Measure Kidney Injury
IL-5 0 timepoint
0.134 pg/ml
Interval 0.0 to 0.808
0.016 pg/ml
Interval 0.0 to 0.58
The Examine and Measure Cytokines to Measure Kidney Injury
IL-5 1 hour post bypass
0.169 pg/ml
Interval 0.0 to 1.145
0.040 pg/ml
Interval 0.0 to 0.789
The Examine and Measure Cytokines to Measure Kidney Injury
IL-5 2 hour post bypass
0.291 pg/ml
Interval 0.0 to 0.901
0.000 pg/ml
Interval 0.0 to 1.104
The Examine and Measure Cytokines to Measure Kidney Injury
IL-5 4 hour post bypass
0.626 pg/ml
Interval 0.0 to 1.089
0.016 pg/ml
Interval 0.0 to 1.083
The Examine and Measure Cytokines to Measure Kidney Injury
IL-5 6 hour post bypass
0.334 pg/ml
Interval 0.0 to 1.252
0.210 pg/ml
Interval 0.0 to 0.9
The Examine and Measure Cytokines to Measure Kidney Injury
IL-5 8 hour post bypass
0.387 pg/ml
Interval 0.02 to 0.574
0.431 pg/ml
Interval 0.0 to 0.796
The Examine and Measure Cytokines to Measure Kidney Injury
IL-5 24 hour post bypass
0.373 pg/ml
Interval 0.0 to 1.366
0.503 pg/ml
Interval 0.055 to 0.794
The Examine and Measure Cytokines to Measure Kidney Injury
IL-7 baseline
4.032 pg/ml
Interval 3.525 to 4.584
2.987 pg/ml
Interval 1.617 to 3.672
The Examine and Measure Cytokines to Measure Kidney Injury
IL-7 0 timepoint
3.673 pg/ml
Interval 2.62 to 6.634
4.311 pg/ml
Interval 2.539 to 5.931
The Examine and Measure Cytokines to Measure Kidney Injury
IL-7 1 hour post bypass
2.973 pg/ml
Interval 2.0 to 4.488
1.822 pg/ml
Interval 1.483 to 4.524
The Examine and Measure Cytokines to Measure Kidney Injury
IL-7 2 hour post bypass
2.469 pg/ml
Interval 1.965 to 4.588
2.104 pg/ml
Interval 1.187 to 4.43
The Examine and Measure Cytokines to Measure Kidney Injury
IL-7 4 hour post bypass
3.061 pg/ml
Interval 2.245 to 4.719
2.530 pg/ml
Interval 1.377 to 3.134
The Examine and Measure Cytokines to Measure Kidney Injury
IL-7 6 hour post bypass
3.391 pg/ml
Interval 2.527 to 4.717
2.317 pg/ml
Interval 1.509 to 3.027
The Examine and Measure Cytokines to Measure Kidney Injury
IL-7 8 hour post bypass
3.506 pg/ml
Interval 1.769 to 4.277
2.354 pg/ml
Interval 1.655 to 4.597
The Examine and Measure Cytokines to Measure Kidney Injury
IL-7 24 hour post bypass
3.656 pg/ml
Interval 0.0 to 4.629
4.097 pg/ml
Interval 1.163 to 5.022
The Examine and Measure Cytokines to Measure Kidney Injury
IL-13 baseline
0.922 pg/ml
Interval 0.0 to 11.185
0.000 pg/ml
Interval 0.0 to 2.027
The Examine and Measure Cytokines to Measure Kidney Injury
IL-13 0 timepoint
0.133 pg/ml
Interval 0.0 to 4.913
0.000 pg/ml
Interval 0.0 to 0.302
The Examine and Measure Cytokines to Measure Kidney Injury
IL-13 1 hour post bypass
0.719 pg/ml
Interval 0.0 to 5.817
0.000 pg/ml
Interval 0.0 to 0.989
The Examine and Measure Cytokines to Measure Kidney Injury
IL-13 2 hour post bypass
2.352 pg/ml
Interval 0.0 to 4.561
1.185 pg/ml
Interval 0.0 to 1.794
The Examine and Measure Cytokines to Measure Kidney Injury
IL-13 4 hour post bypass
1.571 pg/ml
Interval 0.0 to 3.443
0.287 pg/ml
Interval 0.0 to 1.029
The Examine and Measure Cytokines to Measure Kidney Injury
IL-13 6 hour post bypass
1.138 pg/ml
Interval 0.0 to 5.16
0.000 pg/ml
Interval 0.0 to 0.746
The Examine and Measure Cytokines to Measure Kidney Injury
IL-13 8 hour post bypass
0.786 pg/ml
Interval 0.0 to 2.603
0.000 pg/ml
Interval 0.0 to 0.573
The Examine and Measure Cytokines to Measure Kidney Injury
IL-13 24 hour post bypass
0.094 pg/ml
Interval 0.0 to 5.222
0.000 pg/ml
Interval 0.0 to 1.233
The Examine and Measure Cytokines to Measure Kidney Injury
IL-15 baseline
1.905 pg/ml
Interval 0.81 to 6.231
0.969 pg/ml
Interval 0.0 to 2.795
The Examine and Measure Cytokines to Measure Kidney Injury
IL-15 0 timepoint
3.200 pg/ml
Interval 1.493 to 6.739
3.093 pg/ml
Interval 1.483 to 3.914
The Examine and Measure Cytokines to Measure Kidney Injury
IL-15 1 hour post bypass
4.228 pg/ml
Interval 2.92 to 7.884
3.981 pg/ml
Interval 3.016 to 6.153
The Examine and Measure Cytokines to Measure Kidney Injury
IL-15 2 hour post bypass
5.556 pg/ml
Interval 2.814 to 8.172
4.641 pg/ml
Interval 3.381 to 6.86
The Examine and Measure Cytokines to Measure Kidney Injury
IL-15 4 hour post bypass
5.723 pg/ml
Interval 4.258 to 7.128
4.423 pg/ml
Interval 3.542 to 6.768
The Examine and Measure Cytokines to Measure Kidney Injury
IL-15 6 hour post bypass
5.021 pg/ml
Interval 3.049 to 7.138
4.395 pg/ml
Interval 3.004 to 5.526
The Examine and Measure Cytokines to Measure Kidney Injury
IL-15 8 hour post bypass
4.984 pg/ml
Interval 2.873 to 6.096
3.316 pg/ml
Interval 1.841 to 3.989
The Examine and Measure Cytokines to Measure Kidney Injury
IL-15 24 hour post bypass
6.120 pg/ml
Interval 4.023 to 6.695
4.996 pg/ml
Interval 3.434 to 6.161
The Examine and Measure Cytokines to Measure Kidney Injury
IL-17 baseline
1.171 pg/ml
Interval 0.0 to 2.73
0.000 pg/ml
Interval 0.0 to 2.552
The Examine and Measure Cytokines to Measure Kidney Injury
IL-17 0 time point
0.765 pg/ml
Interval 0.0 to 4.558
0.117 pg/ml
Interval 0.0 to 0.943
The Examine and Measure Cytokines to Measure Kidney Injury
IL-17 1 hour post bypass
2.174 pg/ml
Interval 0.202 to 7.78
0.130 pg/ml
Interval 0.0 to 0.768
The Examine and Measure Cytokines to Measure Kidney Injury
IL-17 2 hour post bypass
1.381 pg/ml
Interval 0.475 to 7.394
0.456 pg/ml
Interval 0.0 to 1.228
The Examine and Measure Cytokines to Measure Kidney Injury
IL-17 4 hour post bypass
1.682 pg/ml
Interval 0.412 to 3.982
0.000 pg/ml
Interval 0.0 to 1.899
The Examine and Measure Cytokines to Measure Kidney Injury
IL-17 6 hour post bypass
0.815 pg/ml
Interval 0.196 to 3.582
0.162 pg/ml
Interval 0.0 to 1.29
The Examine and Measure Cytokines to Measure Kidney Injury
IL- 17 8 hour post bypass
0.817 pg/ml
Interval 0.0 to 2.857
0.000 pg/ml
Interval 0.0 to 1.574
The Examine and Measure Cytokines to Measure Kidney Injury
IL-17 24 hour post bypass
0.397 pg/ml
Interval 0.0 to 3.457
0.0000 pg/ml
Interval 0.0 to 2.48
The Examine and Measure Cytokines to Measure Kidney Injury
IP-10 baseline
506.657 pg/ml
Interval 490.553 to 713.745
475.656 pg/ml
Interval 304.609 to 527.253
The Examine and Measure Cytokines to Measure Kidney Injury
IP-10 0 time point
2340.935 pg/ml
Interval 1691.645 to 3585.567
1790.035 pg/ml
Interval 1554.647 to 3807.319
The Examine and Measure Cytokines to Measure Kidney Injury
IP-10 1 hour post bypass
1828.152 pg/ml
Interval 1293.335 to 2297.526
2298.747 pg/ml
Interval 1478.354 to 2763.464
The Examine and Measure Cytokines to Measure Kidney Injury
IP-10 2 hour post bypass
1571.877 pg/ml
Interval 1105.554 to 1991.71
1365.169 pg/ml
Interval 961.057 to 1998.178
The Examine and Measure Cytokines to Measure Kidney Injury
IP-10 4 hour post bypass
1072.023 pg/ml
Interval 910.335 to 1338.142
855.843 pg/ml
Interval 608.726 to 1465.772
The Examine and Measure Cytokines to Measure Kidney Injury
IP-10 6 hour post bypass
704.208 pg/ml
Interval 579.992 to 775.662
575.429 pg/ml
Interval 396.859 to 1059.186
The Examine and Measure Cytokines to Measure Kidney Injury
IP-10 8 hour post bypass
448.938 pg/ml
Interval 292.341 to 570.529
449.376 pg/ml
Interval 295.222 to 675.398
The Examine and Measure Cytokines to Measure Kidney Injury
IP-10 24 hour post bypass
243.332 pg/ml
Interval 213.669 to 265.925
241.467 pg/ml
Interval 157.583 to 333.628
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 alpha baseline
2.251 pg/ml
Interval 0.0 to 4.082
0.000 pg/ml
Interval 0.0 to 3.064
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 alpha 0 time point
8.880 pg/ml
Interval 5.954 to 11.191
10.109 pg/ml
Interval 4.705 to 14.815
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 alpha 1 hour post bypass
9.042 pg/ml
Interval 7.056 to 17.518
9.182 pg/ml
Interval 6.161 to 18.698
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 alpha 2 hour post bypass
6.610 pg/ml
Interval 5.41 to 8.129
6.268 pg/ml
Interval 4.309 to 10.444
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 alpha 4 hour post bypass
4.024 pg/ml
Interval 1.888 to 7.931
4.309 pg/ml
Interval 0.462 to 4.872
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 alpha 6 hour post bypass
3.017 pg/ml
Interval 0.154 to 6.573
0.870 pg/ml
Interval 0.0 to 2.779
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 alpha 8 hour post bypass
1.933 pg/ml
Interval 0.0 to 5.446
0.000 pg/ml
Interval 0.0 to 3.036
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 alpha 24 hour post bypass
1.279 pg/ml
Interval 0.0 to 2.87
0.000 pg/ml
Interval 0.0 to 1.806
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 beta baseline
22.626 pg/ml
Interval 19.968 to 33.454
18.167 pg/ml
Interval 14.254 to 23.434
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 beta 0 time point
55.229 pg/ml
Interval 41.784 to 105.27
47.617 pg/ml
Interval 35.62 to 55.731
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 beta 1 hour post bypass
85.082 pg/ml
Interval 60.08 to 159.731
57.405 pg/ml
Interval 48.3 to 71.806
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 beta 2 hour post bypass
53.750 pg/ml
Interval 38.134 to 86.942
40.900 pg/ml
Interval 34.678 to 48.173
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 beta 4 hour post bypass
34.010 pg/ml
Interval 24.951 to 44.472
24.018 pg/ml
Interval 22.72 to 28.116
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 beta 6 hour post bypass
26.524 pg/ml
Interval 21.681 to 52.531
20.263 pg/ml
Interval 17.094 to 25.972
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 beta 8 hour post bypass
22.676 pg/ml
Interval 17.226 to 37.256
18.522 pg/ml
Interval 16.173 to 24.292
The Examine and Measure Cytokines to Measure Kidney Injury
MIP-1 beta 24 hour post bypass
18.726 pg/ml
Interval 15.327 to 23.802
16.082 pg/ml
Interval 12.354 to 20.734
The Examine and Measure Cytokines to Measure Kidney Injury
G-CSF baseline
50.953 pg/ml
Interval 31.49 to 81.65
43.984 pg/ml
Interval 24.558 to 51.463
The Examine and Measure Cytokines to Measure Kidney Injury
G-CSF 0 time point
92.559 pg/ml
Interval 66.615 to 120.739
150.567 pg/ml
Interval 117.98 to 180.159
The Examine and Measure Cytokines to Measure Kidney Injury
G-CSF 1 hour post bypass
124.298 pg/ml
Interval 76.047 to 150.769
253.527 pg/ml
Interval 176.006 to 281.092
The Examine and Measure Cytokines to Measure Kidney Injury
G-CSF 2 hour post bypass
249.816 pg/ml
Interval 176.392 to 280.874
297.668 pg/ml
Interval 206.217 to 439.136
The Examine and Measure Cytokines to Measure Kidney Injury
G-CSF 4 hour post bypass
285.277 pg/ml
Interval 210.293 to 373.804
311.452 pg/ml
Interval 215.692 to 576.031
The Examine and Measure Cytokines to Measure Kidney Injury
G-CSF 6 hour post bypass
252.546 pg/ml
Interval 193.625 to 305.081
224.425 pg/ml
Interval 197.557 to 382.366
The Examine and Measure Cytokines to Measure Kidney Injury
G-CSF 8 hour post bypass
264.061 pg/ml
Interval 161.506 to 298.064
243.292 pg/ml
Interval 175.307 to 312.665
The Examine and Measure Cytokines to Measure Kidney Injury
G-CSF 24 hour post bypass
309.690 pg/ml
Interval 161.764 to 385.424
199.849 pg/ml
Interval 128.946 to 286.537

PRIMARY outcome

Timeframe: 30 days from the start of infusion

Population: randomized as outlined in the protocol

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.

Outcome measures

Outcome measures
Measure
Nesiritide
n=14 Participants
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours
Placebo
n=15 Participants
infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
The Examine and Measure Endothelin-1 to Measure Kidney Injury
baseline prior to infusion
1.778 pg/ml
Interval 1.443 to 2.149
1.239 pg/ml
Interval 0.991 to 2.557
The Examine and Measure Endothelin-1 to Measure Kidney Injury
time point 0
2.096 pg/ml
Interval 1.899 to 2.568
2.283 pg/ml
Interval 1.924 to 3.077
The Examine and Measure Endothelin-1 to Measure Kidney Injury
1 hour post bypass
1.670 pg/ml
Interval 1.334 to 2.383
2.068 pg/ml
Interval 1.399 to 2.665
The Examine and Measure Endothelin-1 to Measure Kidney Injury
2 hour post bypass
2.173 pg/ml
Interval 1.898 to 2.507
2.201 pg/ml
Interval 1.591 to 2.915
The Examine and Measure Endothelin-1 to Measure Kidney Injury
4 hour post bypass
2.395 pg/ml
Interval 2.237 to 2.988
3.116 pg/ml
Interval 2.157 to 4.45
The Examine and Measure Endothelin-1 to Measure Kidney Injury
6 hour post bypass
2.627 pg/ml
Interval 2.32 to 3.317
3.485 pg/ml
Interval 2.421 to 4.633
The Examine and Measure Endothelin-1 to Measure Kidney Injury
8 hour post bypass
2.744 pg/ml
Interval 2.454 to 3.369
3.143 pg/ml
Interval 2.52 to 4.079
The Examine and Measure Endothelin-1 to Measure Kidney Injury
24 hour post bypass
1.900 pg/ml
Interval 1.55 to 2.901
2.269 pg/ml
Interval 1.688 to 3.541

PRIMARY outcome

Timeframe: A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.

Population: randomized as outlined in protocol

Urinary NGAL,a biomarker for kidney injury was measured.

Outcome measures

Outcome measures
Measure
Nesiritide
n=14 Participants
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours
Placebo
n=15 Participants
infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
The Examine and Measure Urinary NGAL to Measure Kidney Injury
124.566 ng/ml
Interval 29.819 to 340.163
33.766 ng/ml
Interval 9.825 to 425.434

Adverse Events

Nesiritide

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Placebo

Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Nesiritide
n=14 participants at risk
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours
Placebo
n=15 participants at risk
infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
General disorders
Syncope
0.00%
0/14 • June 2010 to December 2012
6.7%
1/15 • Number of events 1 • June 2010 to December 2012
Cardiac disorders
Atrial Fibrillation
0.00%
0/14 • June 2010 to December 2012
6.7%
1/15 • Number of events 1 • June 2010 to December 2012
Respiratory, thoracic and mediastinal disorders
Death
0.00%
0/14 • June 2010 to December 2012
6.7%
1/15 • Number of events 1 • June 2010 to December 2012

Other adverse events

Other adverse events
Measure
Nesiritide
n=14 participants at risk
infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours
Placebo
n=15 participants at risk
infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
Surgical and medical procedures
Mediastinal exploration with evacuation of mediastinal and right clots/blood
7.1%
1/14 • Number of events 1 • June 2010 to December 2012
0.00%
0/15 • June 2010 to December 2012
Cardiac disorders
Chest pain/ dysphagia
7.1%
1/14 • Number of events 1 • June 2010 to December 2012
0.00%
0/15 • June 2010 to December 2012
Respiratory, thoracic and mediastinal disorders
Shotness of breath
0.00%
0/14 • June 2010 to December 2012
6.7%
1/15 • Number of events 1 • June 2010 to December 2012

Additional Information

Dr. Thomas Beaver

University of Florida

Phone: 352-273-5501

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place