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

Phase 4

Completed

Conditions: Postoperative Hypotension
Shock
Hypotension and Shock
Kidney Transplant; Complications
Shock, Surgical
Intraoperative Hypotension

Interventions: Drug: Angiotensin II

Registration Number: NCT04529005

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Angiotensin II (Giapreza)	Angiotensin II	-

Primary Outcome Measures

Name	Time	Method
Duration of ATII Vasopressor Usage in the Intraoperative Setting	Duration of usage during the transplant surgery - presented in hours	Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.

Secondary Outcome Measures

Name	Time	Method
Number (and Percentage) of Patients With 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.	The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record.
Number (and Percentage) of Patients With 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.	The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient.
Number (and Percentage) of Patients With 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)
Number (and Percentage) of Patients With 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.	The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record.
Number (and Percentage) of Patients With 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.	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.
Number (and Percentage) of Patients With Delayed Graft Function	From post-op to 7 days post-op	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.