Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504584-16-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Peripheral noradrenaline will be infused at rates of 0.05-0.15 mcg/kg/min for up to 24 hours after randomization in the ED until shock control is achieved. If shock control cannot be achieved, patients will be transferred to the ICU for further treatment of their condition but without further trial intervention. Weaning of intervention will be completed during the 24 hours, and if possible, terminated. If termination of treatment is not achievable within 24 hours, participants will be transferred to the ICU. |
|
| Control | No Intervention | No ED administered noradrenaline. Standard care of hypotension and shock in the Danish ED's are fluid therapy and if not possible to achieve shock control, they are transferred to the ICU for administration of vasopressors if they are eligible for ICU admittance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noradrenaline | Drug | See arm description |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | At 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 30 days |
| Time without shock within 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients receiving vasopressor at any point 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. | At 24 hours |
| Time to vasopressor initiation |
Inclusion Criteria:
At least 18 years of age
Signs or suspicion of hypotension or shock (of any type such as septic, vasodilatory or hypovolemic not included in the exclusion criteria) defined as:
Received at least 500ml of intravenous fluid before study inclusion (Including prehospital administration) within the first 4 hours of ED arrival.
Clinical Frailty Score (CFS) of ≤4. If CFS is ≥5 and the treating physician find the patient suitable for ICU admittance, the participant can be enrolled, if the on-call ICU doctor would accept the patient for ICU admittance. If the treating physician is unsure of ICU eligibility, regardless of CFS score, the patient should be consulted with the ICU consultant before study inclusion.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lasse P Bentsen, MD | Contact | +4520496950 | lasse.paludan.bentsen@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lasse P Bentsen, MD | Department of Emergency Medicine, Odense University Hospital | Principal Investigator |
| Mikkel Brabrand, MD, PhD | Department of Emergency Medicine, Odense University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Recruiting | Copenhagen | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40197397 | Background | Bentsen LP, Strom T, Forberg JL, Tiwald G, Biesenbach P, Kalmriz M, Rasmussen JH, Raaber N, Moller S, Lokke M, Tygesen GB, Nygaard H, Brok JH, Andersen JW, Bajusz N, Brabrand M. Early initiated noradrenaline versus fluid therapy for hypotension and shock in the emergency department (VASOSHOCK): a protocol for a pragmatic, multi-center, superiority, randomized controlled trial. Scand J Trauma Resusc Emerg Med. 2025 Apr 7;33(1):59. doi: 10.1186/s13049-025-01369-4. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2024 | Jun 26, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2025 | Jun 26, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012769 | Shock |
| D012772 | Shock, Septic |
| D007022 | Hypotension |
| D020896 | Hypovolemia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018805 | Sepsis |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
| At 24 hours |
| 30-day all-cause mortality | Data is extracted from the Danish national registries or the patient's electronic medical records. | At 30 days |
| In-hospital all-cause mortality | Data is extracted from the Danish national registries or the patient's electronic medical records. | At hospital discharge, an average of 30 days efter inclusion |
Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
| At 30 days |
| Hours of vasopressor infusion | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. | At 30 days |
| Proportion of patients with pulmonary oedema within 72 hours | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. | At 72 hours |
| Proportion of patients with acute kidney failure within 72 hours | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. | At 72 hours |
| Number of organ support free days alive within 30 days | Organ support is defined as either mechanical ventilation, vasopressor/inotrope therapy or dialsysis. Data is extracted from the Danish national registries or the patient's electronic medical record. | At 30 days |
| Number of organ support free days alive within 30 days | Organ support is defined as either mechanical ventilation, vasopressor/intotropic therapy or dialysis. Note: Death will count as 0 days. Data is extracted from the Danish national registries or the patient's electronic medical record. | At 30 days |
| Proportion of patients admitted to the ICU | Data is extracted from the patient's electronic medical records. | At 30 days |
| ED Length of stay | Data is extracted from the patient's electronic medical records. | At 72 hours |
| ICU length of stay | Data is extracted from the patient's electronic medical records. | At 30 days |
| Hospital length of stay | Data is extracted from the patient's electronic medical records. | At 30 days |
| Proportion and duration of mechanical ventilation | Data is extracted from the patient's electronic medical records. | At 30 days |
| Proportion and length of renal replacement therapy | Data is extracted from the patient's electronic medical records. | At 30 days |
| Amount of fluid therapy within the first 24 hours | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. | At 24 hours |
| Proportion of serious adverse events for noradrenaline or fluid therapy, e.g. extravasation or overdosis of noradrenaline, pulmonary edema, new cardiac arrhytmias, during the intervention of control period | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. | At 24 hours |
| Esbjerg Hospital | Terminated | Esbjerg | 6700 | Denmark |
| Gødstrup Regional Hospital | Not yet recruiting | Herning | 7400 | Denmark |
|
| Zealand University Hospital | Recruiting | Køge | 4600 | Denmark |
|
| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
|
| Department of Emergency Medicine | Not yet recruiting | Helsingborg | 25223 | Sweden |
|
| Department of Emergency Medicine | Not yet recruiting | Linköping | 58185 | Sweden |
|
| Department of Emergency Medicine | Not yet recruiting | Ystad | 27133 | Sweden |
|
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |