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| Name | Class |
|---|---|
| La Jolla Pharmaceutical Company | INDUSTRY |
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The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiotensin II (Giapreza) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiotensin II | Drug | If intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of ATII Vasopressor Usage in the Intraoperative Setting | Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR. | Duration of usage during the transplant surgery - presented in hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number (and Percentage) of Patients With Arrhythmias | The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record. | From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott T Benken, PharmD | Clinical Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25948896 | Background | Aulakh NK, Garg K, Bose A, Aulakh BS, Chahal HS, Aulakh GS. Influence of hemodynamics and intra-operative hydration on biochemical outcome of renal transplant recipients. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):174-9. doi: 10.4103/0970-9185.155144. | |
| 31514910 | Background | Busse LW, Ostermann M. Vasopressor Therapy and Blood Pressure Management in the Setting of Acute Kidney Injury. Semin Nephrol. 2019 Sep;39(5):462-472. doi: 10.1016/j.semnephrol.2019.06.006. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Angiotensin II (Giapreza) | Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2020 |
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| Number (and Percentage) of Patients With Peripheral/Visceral Ischemia |
The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient. |
| From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
| Number (and Percentage) of Patients With Thrombosis | Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging) | From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
| Number (and Percentage) of Patients With Fungal Infections | The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record. | From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
| Number (and Percentage) of Patients With Hyperglycemia | The presence of hyperglycemia was captured for each patient and was determined by those patients requiring the use of an insulin infusion after their transplant surgery. | From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
| Number (and Percentage) of Patients With Delayed Graft Function | The presence of Delayed Graft Function was captured for each patient and defined by the need for renal replacement therapy up to 7 days post-operative. | From post-op to 7 days post-op |
| 22841277 | Background | Campos L, Parada B, Furriel F, Castelo D, Moreira P, Mota A. Do intraoperative hemodynamic factors of the recipient influence renal graft function? Transplant Proc. 2012 Jul-Aug;44(6):1800-3. doi: 10.1016/j.transproceed.2012.05.042. |
| 24768292 | Background | Day KM, Beckman RM, Machan JT, Morrissey PE. Efficacy and safety of phenylephrine in the management of low systolic blood pressure after renal transplantation. J Am Coll Surg. 2014 Jun;218(6):1207-13. doi: 10.1016/j.jamcollsurg.2014.01.058. Epub 2014 Mar 12. |
| 28072739 | Background | Choi JM, Jo JY, Baik JW, Kim S, Kim CS, Jeong SM. Risk factors and outcomes associated with a higher use of inotropes in kidney transplant recipients. Medicine (Baltimore). 2017 Jan;96(1):e5820. doi: 10.1097/MD.0000000000005820. |
| 20005360 | Background | Ciapetti M, di Valvasone S, di Filippo A, Cecchi A, Bonizzoli M, Peris A. Low-dose dopamine in kidney transplantation. Transplant Proc. 2009 Dec;41(10):4165-8. doi: 10.1016/j.transproceed.2009.08.058. |
| 28528561 | Background | Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21. |
| 29077618 | Background | Lankadeva YR, Kosaka J, Evans RG, Bellomo R, May CN. Urinary Oxygenation as a Surrogate Measure of Medullary Oxygenation During Angiotensin II Therapy in Septic Acute Kidney Injury. Crit Care Med. 2018 Jan;46(1):e41-e48. doi: 10.1097/CCM.0000000000002797. |
| 20381298 | Background | Robert R, Guilhot J, Pinsard M, Longeard PL, Jacob JP, Gissot V, Hauet T, Seguin F. A pair analysis of the delayed graft function in kidney recipient: the critical role of the donor. J Crit Care. 2010 Dec;25(4):582-90. doi: 10.1016/j.jcrc.2010.02.011. Epub 2010 Apr 8. |
| 9850443 | Background | Toth M, Reti V, Gondos T. Effect of recipients' peri-operative parameters on the outcome of kidney transplantation. Clin Transplant. 1998 Dec;12(6):511-7. |
| 29509568 | Background | Tumlin JA, Murugan R, Deane AM, Ostermann M, Busse LW, Ham KR, Kashani K, Szerlip HM, Prowle JR, Bihorac A, Finkel KW, Zarbock A, Forni LG, Lynch SJ, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Bellomo R; Angiotensin II for the Treatment of High-Output Shock 3 (ATHOS-3) Investigators. Outcomes in Patients with Vasodilatory Shock and Renal Replacement Therapy Treated with Intravenous Angiotensin II. Crit Care Med. 2018 Jun;46(6):949-957. doi: 10.1097/CCM.0000000000003092. |
| 23835589 | Background | Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Angiotensin II (Giapreza) | The study group received angiotensin II (Giapreza) as the first continuous infusion vasopressor as clinically indicated for either intraoperative or postoperative hypotension not responsive to fluids or push dose vasopressors (intraoperative only). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Duration of ATII Vasopressor Usage in the Intraoperative Setting | Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR. | Started ATII intraoperatively | Posted | Median | Inter-Quartile Range | hours | Duration of usage during the transplant surgery - presented in hours |
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| Secondary | Number (and Percentage) of Patients With Arrhythmias | The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record. | Posted | Count of Participants | Participants | From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
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| ||||||||||||||||||||||||||||
| Secondary | Number (and Percentage) of Patients With Peripheral/Visceral Ischemia | The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient. | Posted | Count of Participants | Participants | From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
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| Secondary | Number (and Percentage) of Patients With Thrombosis | Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging) | Posted | Count of Participants | Participants | From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
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| Secondary | Number (and Percentage) of Patients With Fungal Infections | The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record. | Posted | Count of Participants | Participants | From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
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| Secondary | Number (and Percentage) of Patients With Hyperglycemia | The presence of hyperglycemia was captured for each patient and was determined by those patients requiring the use of an insulin infusion after their transplant surgery. | Posted | Count of Participants | Participants | From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days. |
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| Secondary | Number (and Percentage) of Patients With Delayed Graft Function | The presence of Delayed Graft Function was captured for each patient and defined by the need for renal replacement therapy up to 7 days post-operative. | Posted | Count of Participants | Participants | From post-op to 7 days post-op |
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30 days
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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 | Angiotensin II (Giapreza) | Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management. | 0 | 20 | 0 | 20 | 1 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | defined as platelet count <50,000 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Benken | University of Illinois Chicago College of Pharmacy | 3123554107 | benken@uic.edu |
| Nov 26, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012773 | Shock, Surgical |
| D012769 | Shock |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000804 | Angiotensin II |
| ID | Term |
|---|---|
| D000809 | Angiotensins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Other |
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