Kidney injury is a common complication following liver transplantation and is associated with
a higher complication rate and increased risk of death. While there are many factors that
likely contribute to kidney injury in the perioperative period, a relative low serum level of
angiotensin 2 (Ang 2) (a protein hormone that causes blood vessels to narrow) found in
patients with liver cirrhosis (late stage of liver damage) may increase their risk of
developing acute kidney injury (sudden episode of kidney failure or damage). We propose to
investigate how early administration of Ang 2, a new vasopressor drug approved by the FDA in
December 2017 for patients with low blood pressure, during the intra-operative period of
liver transplant surgery affects the rate of kidney injury after transplantation. Patients
who are deemed appropriate candidates for the study will be randomized 1:1 to the treatment
and control groups. The intervention period of the study will occur in the operating room
during transplant surgery and will be performed by their anesthesiologists. In the Treatment
group, patients will receive Ang 2 infusions in addition to other standard vasopressors while
patients in the control group will receive standard vasopressors alone. The infusion of Ang 2
in the treatment group will continue through the duration of the surgery and will be stopped
prior to leaving the operating room. Both the treatment group and the control group will then
be followed for 14 days to evaluate rates of kidney injury and to look for any complications.
The follow up period will be extended to 28 days to look at in-hospital mortality rates in
both groups. The daily follow up analysis will occur while the enrolled patients are
inpatient following their transplantation surgery and will be done by looking at lab values
and other data that is routinely gathered by their managing teams. This study will serve as a
pilot study to evaluate feasibility of our protocol and to collect some preliminary data on
the use of Ang 2 in this patient population. As such we plan to enroll approximately 30
patients who have accepted an offer to receive a donor liver. We hope to reach our goal
enrollment within 5 months of starting the study.
Phase:
Phase 4
Details
Lead Sponsor:
University of California, Los Angeles
Treatments:
Angiotensin II Angiotensinogen Epinephrine Giapreza Norepinephrine Vasopressins