Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Starting dose of NE.
- Who it may be relevant to
- Registry conditions: Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other 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.
Primary outcome measures
- Mean arterial blood pressure [Time frame: During first shock episode, up to 28 days of shock episode.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06481839 · 2024-0748