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Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock

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University of Illinois

Status

Not yet enrolling

Conditions

Shock

Treatments

Other: Starting dose of NE

Study type

Interventional

Funder types

Other

Identifiers

NCT06481839
2024-0748

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Low-dose NE
Active Comparator group
Treatment:
Other: Starting dose of NE
High-dose NE
Active Comparator group
Treatment:
Other: Starting dose of NE

Trial contacts and locations

0

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Central trial contact

Scott Benken

Data sourced from clinicaltrials.gov

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