Using Angiotensin-II as a second treatment for septic shock
An Open-label, Single-arm, Single-center Study Evaluating the Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock
This study is testing if adding angiotensin-II to the treatment of patients in septic shock who are already on norepinephrine can improve their recovery and survival in the ICU.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kingman Regional Medical Center Academic / other |
| Locations | 1 site (Kingman, Arizona) |
| Trial ID | NCT06122987 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of angiotensin-II when used as a second vasopressor in patients experiencing septic shock who are already receiving norepinephrine. The research aims to determine how early initiation of angiotensin-II impacts hemodynamic response and overall patient outcomes, including survival rates and ICU stay duration. It will also assess the need for renal replacement therapy and the overall safety and tolerability of the treatment. The study involves administering angiotensin-II alongside hydrocortisone sodium succinate to eligible patients admitted to the ICU.
Who should consider this trial
Good fit: Ideal candidates are adults admitted to the ICU for septic shock requiring norepinephrine support within 12 hours of presentation.
Not a fit: Patients under 18 years old, pregnant or lactating women, and those requiring higher doses of norepinephrine or other vasopressors will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could improve hemodynamic stability and survival rates in patients with septic shock.
How similar studies have performed: Previous studies have shown promise in using angiotensin-II for septic shock, but this specific approach is being evaluated for its timing and efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Age \<18 years * Pregnancy or lactation * Known allergic reactions to angiotensin-II or hydrocortisone sodium succinate * Requiring \>25 mcg/min of norepinephrine or on any vasopressor other than norepinephrine at study enrollment * Clinically significant bleeding precluding the use of chemical prophylaxis for venous thromboembolism * Treatment with another investigational drug or other intervention during study timeframe
Where this trial is running
Kingman, Arizona
- Kingman Regional Medical Center — Kingman, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Tyson Dietrich, PharmD — Kingman Regional Medical Center
- Study coordinator: Tyson Dietrich, PharmD
- Email: TDietrich@azkrmc.com
- Phone: 928-263-3933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.