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Vasopressor
Angiotensin II for Septic Shock
Phase 4
Waitlist Available
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18
Requiring norepinephrine at a dose of 0.05-0.25 mcg/kg/min despite adequate fluid resuscitation
Must not have
History of mesenteric ischemia
Acute coronary syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes after the completion of the angiotensin ii infusion
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial aims to enroll 20 patients with septic shock who need immediate medication support in the emergency department. The main goal is to see if giving angiotensin II early through a vein after
Who is the study for?
This trial is for a small group of 20 patients who arrive at the emergency department with septic shock and need immediate support to maintain blood pressure. Participants must be in a condition where they can receive angiotensin II within three hours after starting norepinephrine, a common drug used to treat low blood pressure.
What is being tested?
The study is testing if giving angiotensin II early on can help treat septic shock in patients who have just arrived at the emergency department. It's a pilot study, which means it's an initial test before larger studies are done.
What are the potential side effects?
While specific side effects are not listed here, angiotensin II may generally increase blood pressure and could potentially cause irregular heartbeats or other cardiovascular issues due to its potent vasoconstrictive effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I need norepinephrine to maintain my blood pressure after receiving enough fluids.
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I am currently on IV antibiotics or will be starting them soon.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a condition where my intestines did not get enough blood.
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I have had a recent heart attack or related condition.
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I have experienced a severe heart condition that suddenly reduced blood flow.
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I have had an aortic dissection or abdominal aortic aneurysm.
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I am currently receiving blood transfusions for severe bleeding.
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I am currently taking two medications to control my blood pressure.
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I have a history of blood clots or cannot take blood clot prevention medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes after the intiation of angiotensin ii infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes after the intiation of angiotensin ii infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of completing all clinical trial activities
Secondary study objectives
Mean arterial pressure response
Mean norepinephrine dose (during angiotensin II infusion)
Mean norepinephrine dose (post angiotensin II infusion)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Angiotensin II InfusionExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiotensin II Infusion
2012
N/A
~30
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
470 Previous Clinical Trials
894,760 Total Patients Enrolled
1 Trials studying Sepsis
1,191 Patients Enrolled for Sepsis