Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-24

Study Completion Date

2028-07-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-dose NE

Group Type ACTIVE_COMPARATOR

Starting dose of NE

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Starting dose of NE

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No