The goal of this pragmatic, multi-center, superiority, randomized clinical trial is to compare early treatment with peripheral (through a vein) infused noradrenaline (a natural hormone that increases blood pressure) with fluid only therapy in patients with hypotensive and shock in the Danish and Swedish Emergency Departments (ED). The main questions it aims to answer are: If early initiated noradrenaline in non-bleeding hypotensive patients presenting in the ED can * Improve time to shock control. * Reduce the need for ICU admittance. * Decrease mortality. Participants will be included by the clinical staff and treated urgently with either noradrenaline or usual treatment during their Emergency Department stay. After completion of the treatment in the Emergency Department, patient data will be extracted from the bed-side measurements, electronic health records and national registers. Patients will be contacted by the research staff 1 year after study inclusion to answer brief questions about their daily physical function and ability to care for themselves. Researchers will compare with patients receiving fluid therapy only, as this is the usual standard of care in Danish and Swedish Emergency Departments.
Please refer to the full protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
See arm description
Bispebjerg Hospital
Copenhagen, Denmark
RECRUITINGEsbjerg Hospital
Esbjerg, Denmark
TERMINATEDGødstrup Regional Hospital
Herning, Denmark
NOT_YET_RECRUITINGZealand University Hospital
Køge, Denmark
RECRUITINGOdense University Hospital
Odense, Denmark
RECRUITINGDepartment of Emergency Medicine
Helsingborg, Sweden
NOT_YET_RECRUITINGDepartment of Emergency Medicine
Linköping, Sweden
NOT_YET_RECRUITINGDepartment of Emergency Medicine
Ystad, Sweden
NOT_YET_RECRUITINGThe primary outcome is the proportion of patients achieving either SBP >100 mmHg or MAP > 65 mmHg or a target blood pressure set by the treating physician at 90 (±15) minutes after inclusion.
Bed-side assessment during treatment and registered in the case report form.
Time frame: At 90 minutes
Number of intensive care unit (ICU) free days alive within 30 days
Data is extracted from the Danish national registries or the patient's electronic medical record. Note: Death will count as 0 days.
Time frame: At 30 days
Time without shock within 24 hours
Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
Time frame: At 24 hours
30-day all-cause mortality
Data is extracted from the Danish national registries or the patient's electronic medical records.
Time frame: At 30 days
In-hospital all-cause mortality
Data is extracted from the Danish national registries or the patient's electronic medical records.
Time frame: At hospital discharge, an average of 30 days efter inclusion
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