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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called angiotensin II (Giapreza) to help manage septic shock, a serious condition where a severe infection causes dangerously low blood pressure. The goal is to determine if adding angiotensin II as a second-line treatment can better stabilize blood pressure when norepinephrine alone is insufficient. Suitable candidates for this trial include those admitted to the ICU within 12 hours for septic shock and currently receiving a specific dose of norepinephrine. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on any vasopressor other than norepinephrine when enrolling in the study.

What is the safety track record for Angiotensin II?

Research has shown that angiotensin II, also known as GIAPREZA, has been tested for safety in people with septic shock. In a study involving 321 adults, researchers closely examined GIAPREZA's safety. The study found that GIAPREZA can help raise blood pressure in patients with septic shock.

Although detailed information about side effects is limited, the treatment was studied in a controlled environment, which helps ensure its safety. Angiotensin II is already approved for use in certain conditions, indicating it is generally well-tolerated.

However, like any treatment, some risks may exist. It's important to consult healthcare professionals to understand how it might affect individuals personally. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for septic shock, which often rely on fluids and vasopressors like norepinephrine to stabilize blood pressure, Angiotensin II offers a fresh approach by directly targeting the renin-angiotensin system. This mechanism can more precisely increase blood pressure in critically ill patients. Researchers are excited because Angiotensin II, also known as Giapreza, has shown the potential to quickly restore blood pressure, which is crucial in managing septic shock and improving patient outcomes.

What evidence suggests that angiotensin II might be an effective treatment for septic shock?

Research has shown that angiotensin II can help treat septic shock. One study found that patients who used angiotensin II had a lower death rate by day 28 compared to those who didn't, indicating a survival benefit. The treatment works better when started early, especially with lower doses of other medications that raise blood pressure. Another study suggested that angiotensin II might improve outcomes in septic shock, making it a promising option for patients. Overall, angiotensin II has been shown to help patients survive and reduce the need for other medications in managing septic shock. Participants in this trial will receive angiotensin II to evaluate its effectiveness in treating septic shock. ^{4 5 6 7 8}

Who Is on the Research Team?

Tyson Dietrich, PharmD

Principal Investigator

Kingman Regional Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9830054/

How Effective is Angiotensin II in Decreasing Mortality of ... The average length of stay in non-shock patient is 3–7 days comparing with shock patient is 16.5 days. The use of Ang-2 showed the potential to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05193370

Angiotensin II vs. Vasopressin in Septic Shock While more studies are needed, preliminary data suggest that the vasopressor angiotensin II (AngII) may improve outcomes in septic shock. This study is a ...

3. giapreza.com giapreza.com/efficacy

Efficacy and Trial Design Survival Data · Increased patient survival at day 28 · Survival benefit was greatest when initiated with lower vasopressor doses · DON'T WAIT—start GIAPREZA sooner ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1704154

Angiotensin II for the Treatment of Vasodilatory Shock Death by day 28 occurred in 75 of 163 patients (46%) in the angiotensin II group and in 85 of 158 patients (54%) in the placebo group (hazard ...

5. annalsofintensivecare.springeropen.com annalsofintensivecare.springeropen.com/articles/10.1186/s13613-025-01522-3

Angiotensin II, conventional vasopressor therapy, and ... Results. Overall 30-day mortality was 56.4%. Groups statistically differed by all baseline variables. In multivariable logistic regression, Ang ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6205124/

Angiotensin II Brings More Questions Than Answers - PMC APACHE II predicts inpatient mortality, and a score of 30 correlates to an expected mortality rate of approximately 70%. Although this was a prespecified ...

7. giapreza.com giapreza.com/safety

Safety & Adverse Events The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in a randomized, double-blind, placebo-controlled study, ATHOS-3.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10882873/

Angiotensin II therapy in refractory septic shock Promising results have been observed in treating refractory hypotension with angiotensin II, which has been shown to increase mean arterial pressure.