Hepatorenal syndrome (HRS) is a disease in which patients with cirrhosis (end stage liver
failure) develop secondary kidney injury and failure. The current treatment available in the
United States is a combination of octreotide and midodrine, which are meant to decrease the
release of those hormones and raise the blood pressure, respectively, which would increase
blood flow to the kidneys. Angiotensin 2 (Ang2) is a new vasopressor drug that was approved
by the FDA in December 2017 for patients with low blood pressure and has been shown to have
similar effects to octreotide and midodrine.
This study will investigate whether Ang2 reverses HRS among patients admitted to the
intensive care unit (ICU) at Ronald Reagan Medical Center. Our study population will be
patients with HRS who are already or will be admitted to the ICU. HRS will be defined by new
internationally accepted guidelines published by the International Club of Ascites. All
patients who are consented will undergo an Ang2 response trial, where low-dose Ang2 will be
administered for 4 hours to see how the patients respond. This will help us characterize the
nature of the patients' kidney failure for later analysis. Patients will then be randomized
into the control group or the study group. Patients in the control group will receive
octreotide (a subcutaneous injection) and midodrine (an oral drug). Patients in the study
group will continue receiving intravenous infusion of Ang2. Patients in both groups will also
receive albumin, a protein found commonly in human blood. Treatment will continue in both
groups for four days, until complete reversal of HRS, dialysis, or death.
Our primary outcome will be rate of reversal of HRS, defined as improvement in kidney
function.
Phase:
Phase 2
Details
Lead Sponsor:
University of California, Los Angeles
Treatments:
Angiotensin II Angiotensinogen Giapreza Midodrine Octreotide