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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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

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Septic Shock Shock Sepsis Systemic Inflammatory Response Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Drug: Angiotensin II Other Names: Giapreza

Group Type EXPERIMENTAL

Angiotensin II and hydrocortisone sodium succinate

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Giapreza

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No