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NCT Number: NCT06481839

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.

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Key information

Conditions

Shock Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean arterial blood pressure

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Scott Benken

CONTACT

[email protected]

312-355-4107

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jul 1, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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