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Trial record 2 of 1573 for:    giapreza

Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT04529005
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
La Jolla Pharmaceutical Company
Information provided by (Responsible Party):
Scott Benken, University of Illinois at Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Shock, Surgical Shock Hypotension and Shock Kidney Transplant; Complications Intraoperative Hypotension Postoperative Hypotension Drug: Angiotensin II Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Angiotensin II (Giapreza) Drug: 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.




Primary Outcome Measures :
  1. Blood Pressure - Intraoperative [ Time Frame: From date and time of study drug initiation during transplant operation until goal BP is attained (per ordering surgeon) to a maximum of 8 hours ]
    Intraoperative - time to attainment of goal BP after starting AT2

  2. Blood Pressure - Postoperative [ Time Frame: From date and time of study drug initiation after transplant operation until goal BP is attained (per ordering surgeon) up to a maximum of 24 hours ]
    Postoperative - time to attainment of goal BP after starting AT2


Secondary Outcome Measures :
  1. Arrhythmias [ Time Frame: 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. ]
    Confirmed via EKG, flowsheet, or note documentation

  2. Peripheral/visceral ischemia [ Time Frame: 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. ]
    Digital or other peripheral/visceral ischemia

  3. Thrombosis [ Time Frame: 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. ]
    Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging)

  4. Fungal Infections [ Time Frame: 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. ]
    Incidence of post-operative fungal infections prior to discharge (as documented by the clinical care team)

  5. Hyperglycemia [ Time Frame: 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. ]
    Incidence of hyperglycemia requiring use of an insulin infusion

  6. Acidemia [ Time Frame: 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. ]
    Incidence of pH < 7.2

  7. Vasopressor outcomes [ Time Frame: Intraoperatively and 72 hour postoperatively ]
    Incidence of the need for additional vasopressor agents

  8. Serum creatinine - 1st post-op [ Time Frame: First SCr after the end of transplant surgery up to 24 hours after surgery is completed ]
  9. Serum creatinine - 7 days post-op [ Time Frame: SCr at postop day 7 ]
  10. Serum creatinine - discharge [ Time Frame: SCr at discharge up to a maximum of 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients > 18 years of age
  • Receiving deceased donor kidney transplant
  • Pre-transplant Ejection Fraction (within past 18 months) > 50%
  • Intraoperative or postoperative distributive shock (according to hospital and study protocol) requiring vasopressor support

Exclusion Criteria:

  • Pregnant patients (they would be excluded from receiving a transplant)
  • Prisoners
  • History of mesenteric ischemia
  • History of aortic dissection
  • History of abdominal aortic aneurysm
  • Allergy to mannitol
  • Absolute neutrophil count < 1000 cell/mm3 (within past 18 months)
  • Diagnosis of Raynaud's phenomenon, systemic sclerosis or vasospastic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529005


Contacts
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Contact: Scott T Benken, PharmD 312-355-4107 benken@uic.edu

Locations
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United States, Illinois
University of Illinois Hospital and Health Sciences System Recruiting
Chicago, Illinois, United States, 60612
Contact: Scott T Benken, PharmD    312-355-4107    benken@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
La Jolla Pharmaceutical Company
Investigators
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Principal Investigator: Scott T Benken, PharmD Clinical Associate Professor
Publications:

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Responsible Party: Scott Benken, Clinical Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04529005    
Other Study ID Numbers: 2020-0526
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Angiotensin II
Giapreza
Hypotension
Shock
Shock, Surgical
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Angiotensinogen
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action