NCT06122987

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kingman Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Septic Shock
• Shock
• Sepsis
• Systemic Inflammatory Response Syndrome

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2023-11-08
• Last updated: 2024-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study