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Vasopressor
Angiotensin II for Septic Shock
Phase 4
Recruiting
Led By Tyson Dietrich, PharmD
Research Sponsored by Kingman Regional Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients admitted to the ICU within 12 hours of presentation to the emergency department for septic shock requiring 15-25 mcg/min of norepinephrine. Septic shock will be defined as having a known or presumed infection with two or more criteria of systemic inflammatory response syndrome, a mean arterial pressure <65 mm Hg despite fluid resuscitation requiring vasopressor support, and a serum lactate >2 mmol/L. Criteria of systemic inflammatory response syndrome include a temperature >100.4°F or <96.8°F; heart rate >90/min; respiratory rate >20/min and a white blood cell count >12,000/mm3 or <4,000/mm3.
Be older than 18 years old
Must not have
Age <18 years
Requiring >25 mcg/min of norepinephrine or on any vasopressor other than norepinephrine at study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
"This trial will evaluate the effectiveness of using angiotensin-II as a secondary medication for septic shock in adults. It is uncertain when to start this medication and how it compares to other vasop
Who is the study for?
This trial is for ICU patients who arrived with septic shock within the last 12 hours, needing moderate norepinephrine doses. They must have a suspected infection, low blood pressure after fluids, need vasopressors, and high lactate levels. Excluded are those not meeting these specific criteria.
What is being tested?
The study tests if adding Angiotensin-II as a second drug improves blood pressure in adults with septic shock already taking norepinephrine. It compares early versus later addition of this drug to see which is more effective.
What are the potential side effects?
Possible side effects include abnormal blood pressure changes, kidney function alterations, and potential interactions with other medications used for treating septic shock.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was admitted to the ICU for septic shock and need a specific medication to maintain my blood pressure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
I need more than 25 mcg/min of norepinephrine or another type of blood pressure medicine.
Select...
I cannot use certain medications for blood clots due to a risk of serious bleeding.
Select...
I am allergic to angiotensin-II or hydrocortisone sodium succinate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The incidence of hemodynamic response, defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 1 hour after initiation of angiotensin-II
Secondary outcome measures
28-day mortality
ICU length of stay
Incidence of adverse reactions
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Drug: Angiotensin II Other Names: Giapreza
Find a Location
Who is running the clinical trial?
Kingman Regional Medical CenterLead Sponsor
2 Previous Clinical Trials
626 Total Patients Enrolled
La Jolla Pharmaceutical CompanyIndustry Sponsor
23 Previous Clinical Trials
2,666 Total Patients Enrolled
Tyson Dietrich, PharmDPrincipal InvestigatorKingman Regional Medical Center
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