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Clinical Trials/NCT06481839
NCT06481839Not yet recruitingNot Applicable

Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock

University of Illinois at Chicago0 sites120 target enrollmentStarted: July 24, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
120
Primary Endpoint
Mean arterial blood pressure
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Scott Benken

Clinical Associate Professor

University of Illinois at Chicago

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