Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06481839

Enrollment

120

Registered

2024-07-01

Start date

2024-07-24

Completion date

2028-07-24

Last updated

2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock

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.

Interventions

OTHERStarting 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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Contacts

Primary ContactScott Benken

benken@uic.edu312-355-4107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026