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Study on Early Use of Norepinephrine vs. Standard Fluid Therapy in Emergency Department Patients with Hypotension or Shock

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of early treatment for patients experiencing shock or hypotension, which is a condition where blood pressure is lower than normal. The study will compare two different approaches to treatment in the emergency department: using a medication called norepinephrine early on, versus the standard approach of primarily using fluid therapy. Norepinephrine is a type of medication known as a vasopressor, which helps to increase blood pressure by narrowing blood vessels.

The purpose of the study is to see if starting treatment with norepinephrine earlier can help control shock more quickly and reduce the need for patients to be admitted to the intensive care unit (ICU). Participants in the study will be randomly assigned to receive either the early norepinephrine treatment or the standard fluid therapy. The study will monitor how quickly patients achieve stable blood pressure and other outcomes such as the number of days they are alive without needing ICU care within 30 days, the time they spend without shock within 24 hours, and mortality rates both in the hospital and within 30 days.

This trial is designed to provide valuable information on whether early intervention with norepinephrine can improve outcomes for patients with shock or hypotension in emergency settings. The study will be conducted over a period of time, with the aim of gathering enough data to make informed conclusions about the effectiveness of early vasopressor therapy compared to standard care.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the inclusion criteria, which include being at least 18 years old and showing signs of low blood pressure or shock.

    Initial treatment with at least 500ml of intravenous fluid is required before joining the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: early vasopressor therapy or standard fluid therapy.

    The aim is to compare the effectiveness of these treatments in managing low blood pressure and shock.

  3. Step 3

    Treatment administration

    If assigned to the early vasopressor group, the medication norepinephrine is administered through an intravenous infusion.

    The dosage and frequency are determined by the medical team based on individual needs.

  4. Step 4

    Monitoring and assessment

    Blood pressure and other vital signs are monitored to assess the effectiveness of the treatment.

    The primary goal is to achieve a blood pressure target within 90 minutes after starting the treatment.

  5. Step 5

    Follow-up

    The number of days without the need for intensive care is recorded over a 30-day period.

    Additional outcomes include the time without shock within 24 hours and mortality rates within 30 days and during the hospital stay.

Who can join the trial?

7 criteria

  • Must be at least 18 years old.
  • Must show signs or have a suspicion of **hypotension** (low blood pressure) or **shock** (a serious condition where blood flow is not enough to meet the body's needs). This can be any type of shock, like septic (due to infection), vasodilatory (blood vessels widen too much), or hypovolemic (not enough blood volume), as long as it's not listed in the exclusion criteria.
  • Blood pressure must be either **SBP** (systolic blood pressure) less than 100 mmHg or **MAP** (mean arterial pressure) less than 65 mmHg, combined with a **lactate** level greater than 2.0 mmol/L. Lactate is a substance in the blood that can indicate stress or lack of oxygen.
  • Alternatively, a doctor can define a specific blood pressure for the patient, combined with a lactate level greater than 2.0 mmol/L.
  • Or, either SBP less than 100 mmHg or MAP less than 65 mmHg with clear signs of shock, regardless of lactate level, as evaluated by two non-specialist doctors or a specialist doctor.
  • Must have received at least 500 ml of intravenous fluid (fluid given directly into a vein) before joining the study. This includes any fluid given before arriving at the emergency department, within the first 4 hours of arrival.
  • Must have a **Clinical Frailty Score (CFS)** of 4 or less. CFS is a way to measure how frail or weak a person is. If the score is 5 or more, the patient can still join if the doctor thinks they are suitable for intensive care unit (ICU) admission and the ICU doctor agrees. If the doctor is unsure about ICU eligibility, they should consult with the ICU consultant before including the patient in the study.

Who cannot join the trial?

2 criteria

  • Patients who are currently experiencing **shock**. Shock is a serious condition where the body is not getting enough blood flow, which can cause organs to stop working properly.
  • Patients with **hypotension**. Hypotension means having low blood pressure, which can lead to dizziness and fainting.
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Investigated drugs

Noradrenaline is a medication used in this trial to help increase blood pressure in patients who are experiencing low blood pressure (hypotension) in the emergency department. It works by narrowing blood vessels, which helps to raise blood pressure and improve blood flow to vital organs. The trial is investigating whether starting treatment with noradrenaline early can help control shock more quickly and reduce the need for intensive care unit (ICU) admission compared to the standard approach of using fluid therapy alone.

What is already known about the treatment

Noradrenaline – Noradrenaline is administered intravenously and is used to treat conditions like shock and low blood pressure (hypotension). It is currently well-established in medical practice and literature as a critical medication for managing acute hypotensive states. The main therapeutic indication for noradrenaline is to quickly restore blood pressure in patients experiencing shock. At the molecular level, noradrenaline works by stimulating alpha-adrenergic receptors, leading to vasoconstriction and increased blood pressure. It is classified pharmacologically as a vasopressor, which means it is used to raise blood pressure in emergency situations.

Investigated diseases

  • Shock

    Shock is a critical condition that occurs when the body is not getting enough blood flow, leading to a lack of oxygen and nutrients to vital organs. It can result from various causes, including severe infection, blood loss, or heart problems. The body may initially try to compensate by increasing heart rate and constricting blood vessels. As shock progresses, blood pressure drops, and organs may begin to fail. Symptoms can include rapid heartbeat, weak pulse, confusion, and cold, clammy skin. Immediate medical attention is crucial to prevent further complications.

  • Hypotension

    Hypotension refers to abnormally low blood pressure, which can cause dizziness, fainting, and in severe cases, shock. It can result from dehydration, heart problems, or endocrine disorders. The condition may be acute or chronic, with symptoms varying based on the underlying cause. In some cases, hypotension can be asymptomatic and not require treatment. However, when symptoms are present, they may include blurred vision, nausea, and fatigue. Monitoring and managing blood pressure levels are important to prevent potential complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504584-16-00Estimated enrolment280 patientsSponsorOdense University Hospital

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