Phase 4
N=20
Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients
Shock, Surgical · Shock · Hypotension and Shock · Kidney Transplant; Complications · Intraoperative Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT04529005 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Duration of ATII Vasopressor Usage in the Intraoperative Setting — 1 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Angiotensin II (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of ATII Vasopressor Usage in the Intraoperative Setting |
1 | — |
| SECONDARY Number (and Percentage) of Patients With Arrhythmias |
1 | — |
| SECONDARY Number (and Percentage) of Patients With Peripheral/Visceral Ischemia |
— | — |
| SECONDARY Number (and Percentage) of Patients With Thrombosis |
— | — |
| SECONDARY Number (and Percentage) of Patients With Fungal Infections |
— | — |
| SECONDARY Number (and Percentage) of Patients With Hyperglycemia |
1 | — |
| SECONDARY Number (and Percentage) of Patients With Delayed Graft Function |
2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04529005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.