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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
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.
Time frame: Duration of usage during the transplant surgery - presented in hours
Number (and Percentage) of Patients With Arrhythmias
The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record.
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.
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.
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.
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)
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.
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.
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.
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.
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.
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.
Time frame: From post-op to 7 days post-op
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