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| ID | Type | Description | Link |
|---|---|---|---|
| 09KW-03 | Other Grant/Funding Number | Florida Department of Health |
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This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nesiritide | Active Comparator | infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours |
|
| Placebo | Placebo Comparator | infuses at 0.01MCG/KG/min for 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nesiritide | Drug | infuses at 0.01MCG/KG/min for 48 hours |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure Neutrophils to Measure Kidney Injury | 0.35 mL of whole blood from each patient was applied to a microfluidics chip to isolate neutrophils. Total RNA was subsequently isolated and gene expression (for all genes listed below) was measured with an Affymetrix gene chip. Data was normalized using RMA (Robust multi-array average) and expressed as log2 expression. | 30 days from the start of infusion |
| The Examine and Measure Cytokines to Measure Kidney Injury | Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines. | 30 days from the start of infusion |
| The Examine and Measure Endothelin-1 to Measure Kidney Injury | Serial measurements of Endothelin-1 levels were measured to determine if natriuretic peptides exert their renal protective effects by preserving renal afferent arteriole flow by antagonizing the vasoconstrictive effects of Endothelin-1. | 30 days from the start of infusion |
| The Examine and Measure Urinary NGAL to Measure Kidney Injury | Urinary NGAL,a biomarker for kidney injury was measured. | A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Beaver, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39878152 | Derived | Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nesiritide | infuses at 0.01 micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours |
| FG001 | Placebo | infuses at 0.01micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nesiritide | infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours |
| BG001 | Placebo | infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measure Neutrophils to Measure Kidney Injury | 0.35 mL of whole blood from each patient was applied to a microfluidics chip to isolate neutrophils. Total RNA was subsequently isolated and gene expression (for all genes listed below) was measured with an Affymetrix gene chip. Data was normalized using RMA (Robust multi-array average) and expressed as log2 expression. | Posted | Mean | Standard Deviation | log2 expression | 30 days from the start of infusion |
|
June 2010 to December 2012
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nesiritide | infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Nesiritide: infuses at 0.01MCG/KG/min for 48 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | General disorders | MedDRA (10.1) | Systematic Assessment | Subject went to the emergency room with a complaint of Syncope. Had surgery for an aortic valve replacement. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mediastinal exploration with evacuation of mediastinal and right clots/blood | Surgical and medical procedures | MedDRA (10.1) | Systematic Assessment | Mediastinal exploration with evacuation of mediastinal and right clots/blood |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Beaver | University of Florida | 352-273-5501 | thomas.beaver@surgery.ufl.edu |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D020097 | Natriuretic Peptide, Brain |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Placebo | Drug | infuses at 0.01MCG/KG/min for 48 hours |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | The Examine and Measure Cytokines to Measure Kidney Injury | Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines. | randomized per protocol | Posted | Median | Inter-Quartile Range | pg/ml | 30 days from the start of infusion |
|
|
|
| Primary | The Examine and Measure Endothelin-1 to Measure Kidney Injury | Serial measurements of Endothelin-1 levels were measured to determine if natriuretic peptides exert their renal protective effects by preserving renal afferent arteriole flow by antagonizing the vasoconstrictive effects of Endothelin-1. | randomized as outlined in the protocol | Posted | Median | Inter-Quartile Range | pg/ml | 30 days from the start of infusion |
|
|
|
| Primary | The Examine and Measure Urinary NGAL to Measure Kidney Injury | Urinary NGAL,a biomarker for kidney injury was measured. | randomized as outlined in protocol | Posted | Median | Inter-Quartile Range | ng/ml | A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed. |
|
|
|
| 0 |
| 14 |
| 2 |
| 14 |
| EG001 | Placebo | infuses at 0.01MCG/KG/min for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours | 3 | 15 | 1 | 15 |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (10.1) | Systematic Assessment | Subject was hospitalized for Atrial Fibrillation. |
|
| Death | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment | Patient expired from respiratory insufficiency and failure. |
|
|
| Chest pain/ dysphagia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment | substernal chest pain and dysphagia |
|
| Shotness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment | post operative visit, admitted due to increased shortness of breath. |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| IL-6 1 hour post bypass |
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| IL-6 2 hour post bypass |
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| IL-6 4hour post bypass |
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| IL-6 6 hour post bypass |
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| IL-6 8 hours post bypass |
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| IL-6 24 hours post bypas |
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| IL8 baseline |
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| IL8- 1 hour post bypass |
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| IL8-2 hour post bypass |
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| IL8 4 hour post bypass |
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| IL8 6 hour post bypass |
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| IL8 8hour post bypass |
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| IL8 24 hour post bypass |
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| IL10 baseline |
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| IL 10 1 hour post bypass |
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| IL10 2 hour post bypass |
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| IL 10 4 hour post bypass |
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| IL 10 6 hour post bypass |
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| IL 10 8 hour post bypass |
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| IL 10 24 hour post bypass |
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| TNF alpha baseline |
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| TNF beta baseline |
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| TNF beta 1 hour post bypass |
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| TNF beta 4 hour post bypass |
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| TNF beta 6 hour post bypass |
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| TNF beta 8 hour post bypass |
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| TNF beta 24 hour post bypass |
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| VEGF baseline |
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| VEGF 1 hour post bypass |
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| VEGF 2 hour post bypass |
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| VEGF 4 hour poswt bypass |
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| VEGF 6 hour post bypass |
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| VEGF 8 hour post bypass |
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| VEGF 24 hour post bypass |
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| MCP-1 baseline |
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| MCP-1 1 hour post bypass |
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| MCP-1 4 hour post bypass |
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| MCP-1 6 hour post bypass |
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| EGF baseline |
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| EGF 1 hour post bypass |
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| EGF 2 hour post bypass |
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| EGF 4 hour post bypass |
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| EGF 6 hour post bypass |
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| EGF 8 post bypass |
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| EGF 24 hour post bypass |
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| IL-1 alpha baseline |
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| IL-1 alpha 1 hour post bypass |
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| IL-1 alpha 2 hour post bypass |
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| IL-1 alpha 4 hour post bypass |
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| IL-1 alpha 6 hour post bypass |
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| IL-1 alpha 8 hour post bypass |
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| IL-1 alpha 24 hour post bypass |
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| IL-1Beta baseline |
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| IL-1Beta 1 hour post bypass |
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| IL-1Beta 2 hour post bypass |
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| IL-1Beta 4 hour post bypass |
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| IL-1Beta 6 hour post bypass |
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| IL-1Beta 8 hour post bypass |
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| IL-1Beta 24 hour post bypass |
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| IL-1RA baseline |
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| IL-1RA 1 hour post bypass |
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| IL-1RA 2 hour post bypass |
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| IL-1RA 4 hour post bypass |
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| IL-1RA 6 hour post bypass |
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| IL-1RA 8 hour post bypass |
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| IL-1RA 24 hour post bypass |
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| IL-2 baseline |
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| IL-2 1 hour post bypass |
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| IL-2 2 hour post bypass |
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| IL-2 4 hour post bypass |
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| IL-2 6 hour post bypass |
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| IL-2 8 hour post bypass |
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| IL-2 24 hour post bypass |
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| IL-3 baseline |
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| IL-3 1 hour post bypass |
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| IL-3 2 hour post bypass |
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| IL-3 4 hour post bypass |
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| IL_3 6 hour post bypass |
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| IL-3 8 hour post bypass |
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| IL_3 24 hour post bypass |
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| IL-4 baseline |
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| IL-4 1 hour post bypass |
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| IL_4 2 hour post bypass |
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| IL-4 4 hour post bypass |
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| IL-4 6 hour post bypass |
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| IL-4 8 hour post bypass |
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| IL_4 24 hour post bypass |
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| IL-5 baseline |
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| IL-5 0 timepoint |
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| IL-5 1 hour post bypass |
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| IL-5 2 hour post bypass |
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| IL-5 4 hour post bypass |
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| IL-5 6 hour post bypass |
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| IL-5 8 hour post bypass |
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| IL-5 24 hour post bypass |
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| IL-7 baseline |
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| IL-7 1 hour post bypass |
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| IL-7 2 hour post bypass |
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| IL-7 4 hour post bypass |
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| IL-7 6 hour post bypass |
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| IL-7 8 hour post bypass |
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| IL-7 24 hour post bypass |
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| IL-13 baseline |
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| IL-13 0 timepoint |
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| IL-13 1 hour post bypass |
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| IL-13 2 hour post bypass |
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| IL-13 4 hour post bypass |
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| IL-13 6 hour post bypass |
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| IL-13 8 hour post bypass |
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| IL-13 24 hour post bypass |
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| IL-15 baseline |
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| IL-15 0 timepoint |
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| IL-15 1 hour post bypass |
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| IL-15 2 hour post bypass |
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| IL-15 4 hour post bypass |
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| IL-15 6 hour post bypass |
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| IL-15 8 hour post bypass |
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| IL-15 24 hour post bypass |
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| IL-17 baseline |
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| IL-17 0 time point |
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| IL-17 1 hour post bypass |
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| IL-17 2 hour post bypass |
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| IL-17 4 hour post bypass |
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| IL-17 6 hour post bypass |
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| IL- 17 8 hour post bypass |
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| IL-17 24 hour post bypass |
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| IP-10 baseline |
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| IP-10 0 time point |
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| IP-10 1 hour post bypass |
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| IP-10 2 hour post bypass |
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| IP-10 4 hour post bypass |
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| IP-10 6 hour post bypass |
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| IP-10 8 hour post bypass |
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| IP-10 24 hour post bypass |
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| MIP-1 alpha baseline |
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| MIP-1 alpha 0 time point |
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| MIP-1 alpha 1 hour post bypass |
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| MIP-1 alpha 2 hour post bypass |
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| MIP-1 alpha 4 hour post bypass |
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| MIP-1 alpha 6 hour post bypass |
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| MIP-1 alpha 8 hour post bypass |
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| MIP-1 alpha 24 hour post bypass |
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| MIP-1 beta baseline |
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| MIP-1 beta 1 hour post bypass |
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| MIP-1 beta 2 hour post bypass |
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| MIP-1 beta 4 hour post bypass |
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| MIP-1 beta 6 hour post bypass |
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| MIP-1 beta 8 hour post bypass |
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| MIP-1 beta 24 hour post bypass |
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| G-CSF baseline |
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| G-CSF 0 time point |
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| G-CSF 1 hour post bypass |
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| G-CSF 2 hour post bypass |
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| G-CSF 4 hour post bypass |
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| G-CSF 6 hour post bypass |
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| G-CSF 8 hour post bypass |
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| G-CSF 24 hour post bypass |
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| 1 hour post bypass |
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| 2 hour post bypass |
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| 4 hour post bypass |
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| 6 hour post bypass |
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| 8 hour post bypass |
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| 24 hour post bypass |
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