In short
There is currently 1 ongoing clinical trial investigating new treatment approaches for shock. This trial is examining whether early use of a medication called norepinephrine can improve outcomes for patients with shock or low blood pressure in emergency department settings, compared to standard fluid therapy. The study is being conducted in Denmark and Sweden.
Clinical trial locations
- Denmark
- Sweden
Study on Early Use of Norepinephrine vs. Standard Fluid Therapy in Emergency Department Patients with Hypotension or Shock
This trial is investigating whether starting treatment with a blood pressure medication called norepinephrine earlier in the emergency department can help patients with shock or low blood pressure recover more quickly. The study compares this early medication approach to the standard treatment of primarily using intravenous fluids.
Who can participate:
- Adults aged 18 years or older
- Patients showing signs of low blood pressure or shock, including conditions caused by infection, blood vessel widening, or low blood volume
- People with systolic blood pressure below 100 mmHg or mean arterial pressure below 65 mmHg, combined with lactate levels above 2.0 mmol/L (lactate is a substance indicating stress or lack of oxygen in the body)
- Patients who have already received at least 500 ml of intravenous fluid before joining the study
- Those with a Clinical Frailty Score of 4 or less (a measure of overall health and frailty). Patients with a score of 5 or higher may still qualify if their doctor believes they are suitable for intensive care unit admission
Who cannot participate:
- Patients already experiencing active shock at the time of enrollment
- Those currently having hypotension (low blood pressure) at enrollment
What the trial involves:
Participants will be randomly assigned to one of two groups. One group will receive early treatment with norepinephrine, a medication that helps increase blood pressure by narrowing blood vessels. The other group will receive standard fluid therapy. The medical team will closely monitor blood pressure and other vital signs throughout the treatment. The main goal is to see if the blood pressure target can be achieved within 90 minutes of starting treatment.
Investigational drug:
The trial is studying norepinephrine (also called noradrenaline), a vasopressor medication that raises blood pressure by causing blood vessels to constrict. It is administered through an intravenous infusion, with the dosage adjusted based on each patient's individual needs. This medication is already widely used in medical practice for managing acute low blood pressure states, but this study aims to determine whether starting it earlier in the emergency department can improve patient outcomes.
What researchers will measure:
The study will track several important outcomes, including how quickly patients achieve stable blood pressure, the number of days patients remain alive without needing intensive care within 30 days, the time spent without shock within the first 24 hours, and mortality rates both during hospital stay and within 30 days of treatment.
Summary
Currently, there is one active clinical trial investigating treatment approaches for shock. This trial focuses on emergency department management and is examining whether early intervention with a blood pressure-raising medication can improve outcomes compared to standard fluid therapy alone. The study is being conducted across two Scandinavian countries, Denmark and Sweden, reflecting an international collaborative effort to improve emergency care for patients experiencing shock or dangerously low blood pressure.
The trial specifically investigates norepinephrine, a well-established medication in emergency medicine, but explores a new timing strategy for its use. By studying early administration in the emergency department rather than waiting until patients deteriorate further, researchers hope to determine whether this approach can reduce the need for intensive care admission and improve overall patient outcomes.
