RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-04
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06122987

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * Age \<18 years
  2. * Pregnancy or lactation
  3. * Known allergic reactions to angiotensin-II or hydrocortisone sodium succinate
  4. * Requiring \>25 mcg/min of norepinephrine or on any vasopressor other than norepinephrine at study enrollment
  5. * Clinically significant bleeding precluding the use of chemical prophylaxis for venous thromboembolism
  6. * Treatment with another investigational drug or other intervention during study timeframe

Contacts and Locations

Study Contact

Tyson Dietrich, PharmD
CONTACT
928-263-3933
TDietrich@azkrmc.com
Anthony Santarelli, PhD
CONTACT
928-757-0649
anthony.santarelli@azkrmc.com

Principal Investigator

Tyson Dietrich, PharmD
PRINCIPAL_INVESTIGATOR
Kingman Regional Medical Center

Study Locations (Sites)

Kingman Regional Medical Center
Kingman, Arizona, 86401
United States

Collaborators and Investigators

Sponsor: Kingman Regional Medical Center

  • Tyson Dietrich, PharmD, PRINCIPAL_INVESTIGATOR, Kingman Regional Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04
Study Completion Date2025-01

Study Record Updates

Study Start Date2023-12-04
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • Sepsis
  • Angiotensin II
  • Hydrocortisone

Additional Relevant MeSH Terms

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