Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock

Kingman Regional Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Shock; Systemic Inflammatory Response Syndrome; Septic Shock; Sepsis

Treatments: Drug: Angiotensin II and hydrocortisone sodium succinate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06122987

KRMC 0284

Details and patient eligibility

About

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.

Full description

Objectives:

Primary Objective:

1. To evaluate the efficacy of ang-II when used as the second vasopressor agent for septic shock

Secondary Objectives:

1. To assess the duration of response to ang-II
2. To assess overall survival
3. To assess the amount of time spent in the ICU
4. To assess the need for renal replacement therapy
5. To assess the overall duration of vasoactive medication use
6. To assess toxicity and tolerability

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Single Arm

Experimental group

Description:

Drug: Angiotensin II Other Names: Giapreza

Treatment:

Drug: Angiotensin II and hydrocortisone sodium succinate