Trials / Completed
CompletedNCT04529005
Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients
Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Illinois at Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Shock, Surgical
- Shock
- Hypotension and Shock
- Kidney Transplant; Complications
- Intraoperative Hypotension
- Postoperative Hypotension
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-08-13
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2020-08-27
- Last updated
- 2022-12-21
- Results posted
- 2022-12-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04529005. Inclusion in this directory is not an endorsement.