Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock

This study is designed to assess the effect of initial vasopressor dose on clinical outcomes. To date, there are no clinical guidelines or recommendations regarding the dose of vasopressor medication that should be initiated before titrating to a mean arterial pressure (MAP) in patients with circulatory shock. High heterogeneity and clinical equipoise regarding this variable exist in routine clinical practice. However, there is strong evidence that delays in achieving MAP goals lead to worse clinical outcomes. The study will randomize patients with circulatory shock to a low (5mcg/min of norepinephrine) or high (15mcg/min of norepinephrine) initial starting dose followed by the usual protocolized titration to MAP goal. The time to reach the goal MAP, organ dysfunction, hospital length of stay, and mortality will be measured for each group.

Study Overview

• Status: Not yet recruiting
• Conditions: Shock
• Intervention / Treatment: Other: Starting dose of NE

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott Benken; Phone Number: 312-355-4107; Email: benken@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients at least 18 years old
• Patients who are diagnosed with shock (MAP < 65 mmHg) require the initiation of vasopressors
• Care provided in the ED or admission to the Medical Intensive Care Unit (MICU)
• Norepinephrine chosen as first-line vasopressor by the treating clinician

Exclusion Criteria:

• Patients who are receiving vasopressors or inotropes prior to UI Health hospital presentation/admission
• Baseline MAP >/= 65 mmHg
• Pregnant patients (checked as standard of care on admission)
• Prisoners.
• Immediate post-cardiac arrest patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-dose NE	Other: Starting dose of NE; Patients will be randomized to either low-dose (5mcg/min) or high-dose (15mcg/min) norepinephrine (NE) for their first vasopressor in shock.
Active Comparator: High-dose NE	Other: Starting dose of NE; Patients will be randomized to either low-dose (5mcg/min) or high-dose (15mcg/min) norepinephrine (NE) for their first vasopressor in shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial blood pressure	Time to achieve and sustain a mean arterial pressor greater than or equal to 65 mmHg	During first shock episode, up to 28 days of shock episode.

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): July 24, 2024
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): July 24, 2028

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Estimated): July 1, 2024

Study Record Updates

• Last Update Posted (Estimated): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 2024-0748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No