Angiotensin II for Septic Shock

Overseen By Anthony Santarelli, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Kingman Regional Medical Center

Must be taking: Norepinephrine

Must not be taking: Other vasopressors

Disqualifiers: Pregnancy, Bleeding, Investigational drugs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Norepinephrine is a catecholamine that is the first-line vasopressor for septic shock. The addition of non-catecholamine vasopressors, including vasopressin and angiotensin-II may be used in adults with septic shock that have inadequate mean arterial pressure while on norepinephrine. Uncertainty exists regarding the timing of initiation of these agents and there is a lack of data comparing their safety and efficacy. The current literature suggests that earlier initiation of angiotensin-II will have a more significant reduction on norepinephrine-equivalent dose compared to later initiation. In addition, approximately half of patients initiated on vasopressin do not have an early hemodynamic response 6 hours after initiation. The purpose of this study is to evaluate the efficacy of angiotensin-II when used as the second vasopressor agent for septic shock.

Research Team

Tyson Dietrich, PharmD

Principal Investigator

Kingman Regional Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I was admitted to the ICU for septic shock and need a specific medication to maintain my blood pressure.

Exclusion Criteria

Treatment with another investigational drug or other intervention during study timeframe

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive angiotensin-II as the second vasopressor agent for septic shock

1 year

Frequent monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Treatment Details

Interventions

• Angiotensin II

Trial Overview 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.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Drug: Angiotensin II Other Names: Giapreza

Angiotensin II is already approved in United States for the following indications:

Approved in United States as Giapreza for:

• Septic shock
• Vasodilatory shock

Who Is Running the Clinical Trial?

Kingman Regional Medical Center

Lead Sponsor

Trials

3

Recruited

680+

La Jolla Pharmaceutical Company

Industry Sponsor

Trials

24

Recruited

2,700+