Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Duration of ATII Vasopressor Usage in the Intraoperative Setting
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Angiotensin II (Giapreza)
干预措施: Angiotensin II (Drug)
结局指标
主要结局
Duration of ATII Vasopressor Usage in the Intraoperative Setting
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- Number (and Percentage) of Patients With Delayed Graft Function(From post-op to 7 days post-op)
研究者
Scott Benken
Clinical Associate Professor
University of Illinois at Chicago