Angiotensin II for Vasoplegic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Vasoplegic Syndrome+1 MoreAngiotensin II - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether Angiotensin II is effective and safe as a second-line vasopressor during liver transplantation.

Eligible Conditions
  • Liver Transplant Complications
  • Vasoplegic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: 1 year

1 year
Patient and graft survival at 1 year after LT
3 days
Model for Early Allograft Function (MEAF) score
30 days
Major adverse kidney events (MAKE) at 30 days (MAKE-30) after LT
Patient and graft survival at 30 days after LT
48 hours
Kidney Failure, Acute
7 days
Incidence of early allograft dysfunction (EAD) by Olthoff criteria
Hour 8
Change in intraoperative urine output in mL/kg/hr before and after initiation of study drug
Dose of epinephrine administered during LT, excluding boluses within the 5 min immediately following portal reperfusion, averaged over case duration and TBW.
Dose of vasopressin administered during LT, averaged over case duration and TBW.
Proportion of patients requiring 3rd and 4th line vasopressor infusions (epinephrine or vasopressin) during LT
Time spent below target MAP (65 mmHg)
Total dose of norepinephrine (NE), averaged over case duration and total body weight, utilized during liver transplantation (LT) to maintain mean arterial pressure (MAP) greater than or equal to 65 mmHg.
Hour 4
Body Weight Changes
Up to 1 year
Duration of ICU stay after LT
Duration of hospital stay after LT
Duration of renal replacement therapy (RRT) after LT

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Angiotensin II (Giapreza)
1 of 2
Saline
1 of 2

Experimental Treatment

Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Angiotensin II · Has Placebo Group · Phase 2 & 3

Angiotensin II (Giapreza)
Drug
Experimental Group · 1 Intervention: Angiotensin II · Intervention Types: Drug
Saline
Drug
PlaceboComparator Group · 1 Intervention: Saline · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiotensin II
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

La Jolla Pharmaceutical CompanyIndustry Sponsor
21 Previous Clinical Trials
2,616 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,283 Previous Clinical Trials
11,577,605 Total Patients Enrolled
Michael P Bokoch, M.D., Ph.D.Principal InvestigatorDepartment of Anesthesia and Perioperative Care, University of California, San Francisco
Erika L Brinson, M.D.Principal InvestigatorDepartment of Anesthesia and Perioperative Care, University of California, San Francisco

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years of age or older.
You have a MELD-Na score of 25 or higher at the time of transplant, not counting any special exception points.
You need a dosage of greater than 0.05 micrograms per kilogram of body weight in norepinephrine (NE) during your long-term treatment.
References