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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

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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 below

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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:

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I am under 18 years old.

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I need more than 25 mcg/min of norepinephrine or another type of blood pressure medicine.

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I cannot use certain medications for blood clots due to a risk of serious bleeding.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

28-day mortality

ICU length of stay

Incidence of adverse reactions

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