RECRUITING

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

Description

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 ShockShockSepsisSystemic Inflammatory Response Syndrome
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Related Conditions:

Septic ShockShockSepsisSystemic Inflammatory Response Syndrome

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Septic Shock
Intervention / Treatment

-

Contacts and Locations

Kingman

Kingman Regional Medical Center, Kingman, Arizona, United States, 86401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kingman Regional Medical Center,

Tyson Dietrich, PharmD, PRINCIPAL_INVESTIGATOR, Kingman Regional Medical Center

Study Record Dates

2025-01