Trial Outcomes & Findings for Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients (NCT NCT04529005)

NCT ID: NCT04529005

Last Updated: 2022-12-21

Results Overview

Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Duration of usage during the transplant surgery - presented in hours
• Results posted on: 2022-12-21

Participant Flow

Participant milestones

Measure	Angiotensin II (Giapreza) 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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Angiotensin II (Giapreza) n=20 Participants The study group received angiotensin II (Giapreza) as the first continuous infusion vasopressor as clinically indicated for either intraoperative or postoperative hypotension not responsive to fluids or push dose vasopressors (intraoperative only).
Age, Continuous	56.3 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants
Race/Ethnicity, Customized Black	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of usage during the transplant surgery - presented in hours

Population: Started ATII intraoperatively

Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.

Outcome measures

Measure	Angiotensin II (Giapreza) n=16 Participants 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	1 hours Interval 0.5 to 2.0

SECONDARY outcome

Timeframe: 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.

The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record.

Outcome measures

Measure	Angiotensin II (Giapreza) n=20 Participants 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.
Number (and Percentage) of Patients With Arrhythmias	1 Participants

SECONDARY outcome

Timeframe: 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.

The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient.

Outcome measures

Measure	Angiotensin II (Giapreza) n=20 Participants 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.
Number (and Percentage) of Patients With Peripheral/Visceral Ischemia	0 Participants

SECONDARY outcome

Timeframe: 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.

Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging)

Outcome measures

Measure	Angiotensin II (Giapreza) n=20 Participants 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.
Number (and Percentage) of Patients With Thrombosis	0 Participants

SECONDARY outcome

Timeframe: 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.

The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record.

Outcome measures

Measure	Angiotensin II (Giapreza) n=20 Participants 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.
Number (and Percentage) of Patients With Fungal Infections	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Angiotensin II (Giapreza) n=20 Participants 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.
Number (and Percentage) of Patients With Hyperglycemia	1 Participants

SECONDARY outcome

Timeframe: From post-op to 7 days post-op

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.

Outcome measures

Measure	Angiotensin II (Giapreza) n=20 Participants 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.
Number (and Percentage) of Patients With Delayed Graft Function	2 Participants

Adverse Events

Angiotensin II (Giapreza)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Angiotensin II (Giapreza) n=20 participants at risk 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.
Blood and lymphatic system disorders Thrombocytopenia	5.0% 1/20 • Number of events 1 • 30 days

Additional Information

Scott Benken

University of Illinois Chicago College of Pharmacy

Phone: 3123554107

Email: benken@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place