A Phase 4 interventional study of Angiotensin II in Shock, Surgical, Shock and Hypotension and Shock, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by University of Illinois at Chicago · Phase 4, Interventional, and Treatment
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Duration of ATII Vasopressor Usage in the Intraoperative Setting
Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.
Time frame: Duration of usage during the transplant surgery - presented in hours
Number (and Percentage) of Patients With Arrhythmias
The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record.
Time frame: 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
The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient.
Time frame: 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
Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging)
Time frame: 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
The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record.
Time frame: 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
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.
Time frame: 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
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.
Time frame: From post-op to 7 days post-op
| Milestone | Angiotensin II (Giapreza) |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.
| hours | Angiotensin II (Giapreza) |
|---|---|
| Duration of ATII Vasopressor Usage in the Intraoperative Setting | 1 (0.5 to 2) |
The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record.
| Participants | Angiotensin II (Giapreza) |
|---|---|
| Number (and Percentage) of Patients With Arrhythmias | 1 |
The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient.
| Participants | Angiotensin II (Giapreza) |
|---|---|
| Number (and Percentage) of Patients With Peripheral/Visceral Ischemia | 0 |
Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging)
| Participants | Angiotensin II (Giapreza) |
|---|---|
| Number (and Percentage) of Patients With Thrombosis | 0 |
The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record.
| Participants | Angiotensin II (Giapreza) |
|---|---|
| Number (and Percentage) of Patients With Fungal Infections | 0 |
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.
| Participants | Angiotensin II (Giapreza) |
|---|---|
| Number (and Percentage) of Patients With Hyperglycemia | 1 |
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.
| Participants | Angiotensin II (Giapreza) |
|---|---|
| Number (and Percentage) of Patients With Delayed Graft Function | 2 |
Collected over 30 days. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Angiotensin II (Giapreza) | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Event | Angiotensin II (Giapreza) |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 1/20 |
| Age, Continuous(years) | Angiotensin II (Giapreza) |
|---|---|
| Mean | 56.3 ± 10.7 |
| Sex: Female, Male(Participants) | Angiotensin II (Giapreza) |
|---|---|
| Female | 9 |
| Male | 11 |
| Race/Ethnicity, Customized(Participants) | Angiotensin II (Giapreza) |
|---|---|
| White | 6 |
| Black | 7 |
| Hispanic | 5 |
| Other | 2 |
| Region of Enrollment(Participants) | Angiotensin II (Giapreza) |
|---|---|
| United States | 20 |
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University of Illinois at Chicago