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

NCT06122987 | Recruiting Phase 4 FDA Drug

• 1 other identifier: KRMC 0284
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock; Shock; Sepsis; Systemic Inflammatory Response Syndrome

Keywords

Sepsis; Angiotensin II; Hydrocortisone

Outcome Measures

Primary Outcomes (1)

• The 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.

  1 hour

Secondary Outcomes (7)

• The incidence of hemodynamic response at 3 hours after initiation of angiotensin-II

  3 hours

• The incidence of hemodynamic response at 6 hours after initiation of angiotensin-II

  6 hours

• 28-day mortality

  28 days

• ICU length of stay

  1 year

• Need for renal replacement therapy

  1 year

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Angiotensin II Other Names: Giapreza

Drug: Angiotensin II and hydrocortisone sodium succinate

Interventions

Angiotensin II and hydrocortisone sodium succinate DRUG

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

Also known as: Giapreza

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kingman Regional Medical Center: lead
• La Jolla Pharmaceutical Company: collaborator

Study Sites (1)

Kingman Regional Medical Center

Kingman, Arizona, 86401, United States

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Shock; Sepsis; Systemic Inflammatory Response Syndrome

Interventions

Angiotensin II; Hydrocortisone; Giapreza

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angiotensins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Autacoids; Inflammation Mediators; Biological Factors; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; 17-Hydroxycorticosteroids

Study Officials

• Tyson Dietrich, PharmD

  Kingman Regional Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyson Dietrich, PharmD

CONTACT

928-263-3933; TDietrich@azkrmc.com

Anthony Santarelli, PhD

CONTACT

928-757-0649; anthony.santarelli@azkrmc.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: December 4, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)