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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Intravenous infusion angiotensin II (titrated for each individual patient by effect) and hydrocortisone 50 mg intravenous bolus every 6 hours.
Kingman Regional Medical Center
Kingman, Arizona, United States
RECRUITINGThe 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
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
The incidence of hemodynamic response at 3 hours after initiation of angiotensin-II
Defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 3 hours after initiation of angiotensin-II.
Time frame: 3 hours
The incidence of hemodynamic response at 6 hours after initiation of angiotensin-II
Defined as a decrease in norepinephrine-equivalent dose with a MAP ≥65 mm Hg at 6 hours after initiation of angiotensin-II.
Time frame: 6 hours
28-day mortality
Defined as all cause mortality up to 28 days from study enrollment.
Time frame: 28 days
ICU length of stay
Defined as the time spent within the ICU until discharge to a step down unit.
Time frame: 1 year
Need for renal replacement therapy
Defined as patients started on either continuous renal replacement therapy (CRRT) or intermittent hemodialysis (IHD) during the study period.
Time frame: 1 year
Vasoactive medication duration overall
Defined as the duration (hours) of vasoactive medication use during the study period.
Time frame: 1 year
Incidence of adverse reactions
Define as an unexpected or unintended effect suspected to be caused by a medicine.
Time frame: 1 year
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