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

University of Illinois

Status and phase: Completed; Phase 4

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

Treatments: Drug: Angiotensin II

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04529005

2020-0526

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Angiotensin II (Giapreza)

Experimental group

Treatment:

Drug: Angiotensin II