Recruiting

Angiotensin-II

Sponsor:

Kingman Regional Medical Center

Code:

NCT06122987

Conditions

Septic Shock

Shock

Sepsis

Systemic Inflammatory Response Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Angiotensin II and hydrocortisone sodium succinate

Study Details

Brief summary:

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.

Conditions

Septic Shock

Shock

Sepsis

Systemic Inflammatory Response Syndrome

Study ID

NCT06122987

Start date

Dec 4, 2023

Status verified date

May, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm

Drug: Angiotensin II Other Names: Giapreza

Interventions

Angiotensin II and hydrocortisone sodium succinate

Intravenous infusion angiotensin II (titrated for each individual patient by effect) and hydrocortisone 50 mg intravenous bolus every 6 hours.

Primary outcome measure

  • 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 [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Tyson Dietrich, PharmD

928-263-3933TDietrich@azkrmc.com

Anthony Santarelli, PhD

928-757-0649anthony.santarelli@azkrmc.com

Locations

Kingman Regional Medical Center

Recruiting

Kingman, Arizona, United States, 86401

Contacts

Tyson Dietrich, PharmD

928-263-3933tdietrich@azkrmc.org

More Information

Sponsor

Kingman Regional Medical Center

Last update posted

May 23, 2024

Last verified

May, 2024

Keywords

  • Sepsis
  • Angiotensin II
  • Hydrocortisone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kingman Regional Medical Center on 2024-05-23.