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Vasopressor

Angiotensin II for AKI after Liver Transplantation

Phase 4
Waitlist Available
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable renal function in the 48 hours prior to transplant (defined as < 30% change in serum creatinine)
Adult patients > 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial will investigate whether the administration of angiotensin 2, a new vasopressor drug, during liver transplant surgery can decrease the rate of kidney injury after transplantation.

Who is the study for?
This trial is for adults over 18 with end-stage liver disease who are about to receive a liver transplant and have had stable kidney function in the last 48 hours. It's not for those on dialysis, recent stroke or heart attack survivors, people with clotting disorders, heart failure patients, or those allergic to study drugs.Check my eligibility
What is being tested?
The trial tests if Angiotensin II (Ang 2), a new vasopressor drug given during liver transplant surgery can reduce kidney injury after the operation. Patients will be randomly assigned to either get Ang 2 plus standard treatment or just standard treatment alone.See study design
What are the potential side effects?
Possible side effects of Angiotensin II include increased blood pressure, potential impact on kidney function and interactions with other medications used during surgery. Close monitoring will occur to manage any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function has been stable for the last 2 days.
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I am older than 18 years.
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I have end-stage liver disease and have been accepted for a liver transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Acute kidney Injury
Secondary outcome measures
Adverse events
In hospital mortalituy
Need for Renal Replacement therapies
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
Patients assigned to the study group will receive Ang 2 infusion in addition to standard vasopressor regimen. Ang 2 is currently approved at UCLA as a second line vasopressor and will be used as such for the purposes of our study. Hemodynamic goals will be established at the beginning of the case by the anesthesiology and surgical teams. Ang 2 will be started as a second vasopressor once the norepinephrine dose has reached 0.05mcg/kg/min. Ang 2 will be initiated at a starting dose of 5ng/kg/min. That dose will be up titrated one time to 10ng/kg/min as vasopressor requirements escalate. Once a patient is on the 10ng/kg/min dose of ang 2, no additional up titration will be performed. Hemodynamic management will continue throughout the case with titration of other vasopressors as needed. Ang 2 will be continued throughout the intraoperative period but will be weaned off prior to leaving the operating room.
Group II: ControlActive Control1 Intervention
Patients assigned to the control group will undergo intraoperative management with a standard vasopressor regimen composed of norepinephrine, vasopressin and epinephrine based on hemodynamic goals established by the surgical and anesthesia teams prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiotensin II
2010
Completed Phase 4
~260
Norepinephrine
2014
Completed Phase 4
~1780

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,518 Previous Clinical Trials
10,278,730 Total Patients Enrolled
2 Trials studying Liver Cirrhosis
145 Patients Enrolled for Liver Cirrhosis

Media Library

Angiotensin II (Vasopressor) Clinical Trial Eligibility Overview. Trial Name: NCT04592744 — Phase 4
Liver Cirrhosis Research Study Groups: Intervention, Control
Liver Cirrhosis Clinical Trial 2023: Angiotensin II Highlights & Side Effects. Trial Name: NCT04592744 — Phase 4
Angiotensin II (Vasopressor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04592744 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Sep 2024