Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock

NCT06481839 | Not Yet Recruiting

• 1 other identifier: 2024-0748
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Shock

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Low-dose NE

ACTIVE COMPARATOR

Other: Starting dose of NE

High-dose NE

ACTIVE COMPARATOR

Other: Starting dose of NE

Interventions

Starting dose of NE OTHER

Patients will be randomized to either low-dose (5mcg/min) or high-dose (15mcg/min) norepinephrine (NE) for their first vasopressor in shock.

High-dose NE; Low-dose NE

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Scott Benken

CONTACT

312-355-4107; benken@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 1, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): July 24, 2028
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share