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

1 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Skane Helsingborg Hospital	Helsingborg	Sweden
Region Skane Lasarettet I Ystad	Ystad	Sweden
Sjællands Universitetshospital	Koege	Denmark
Odense University Hospital	Odense	Denmark
Rhwufc Mgxrwfkrbuw	Herning	Denmark
Aixkzx Uletqjjvyi Hbdvlbrv	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.10.2023
Sweden	Recruiting	01.10.2023

Trial locations

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.

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 ID:

2023-504584-16-00

NCT ID:

NCT05931601

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?