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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT04529005
Collaborator
La Jolla Pharmaceutical Company (Industry)
20
Enrollment
1
Location
1
Arm
11.6
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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

  1. 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
  • Drug: Angiotensin II
 Phase 4

Study Design

Study Type:
Interventional
Actual 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 :
Aug 13, 2020
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Aug 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Blood Pressure - Intraoperative [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 [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 [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 [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 [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 [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 [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 [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 [Intraoperatively and 72 hour postoperatively]

    Incidence of the need for additional vasopressor agents

  8. Serum creatinine - 1st post-op [First SCr after the end of transplant surgery up to 24 hours after surgery is completed]

  9. Serum creatinine - 7 days post-op [SCr at postop day 7]

  10. Serum creatinine - discharge [SCr at discharge up to a maximum of 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois Hospital and Health Sciences System Chicago Illinois United States 60612

Sponsors and Collaborators

  • University of Illinois at Chicago
  • La Jolla Pharmaceutical Company

Investigators

  • Principal Investigator: Scott T Benken, PharmD, Clinical Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Scott Benken, Clinical Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT04529005
Other Study ID Numbers:
  • 2020-0526
First Posted:
Aug 27, 2020
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Hypotension
Shock
Shock, Surgical
Angiotensin II
Giapreza
Angiotensinogen

Study Results

No Results Posted as of Aug 16, 2021