ShockPhase 3VASOSHOCKNCT05931601
Early Initiated Vasopressor Therapy in the Emergency Department
A Phase 3 study testing Noradrenaline in people with Shock and Shock, Septic, run by Odense University Hospital at 8 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Shock, Septic, Hypotension
- What is being tested?
- Noradrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 8 Dec 2023to 31 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- SBP < 100mmHg or MAP < 65 mmHg combined with lactate > 2.0 mmol/L,
- Physician defined blood pressure for the individual patient combined with a lactate > 2.0 mmol/L
- Either SBP < 100mmHg or MAP < 65mmHg with obvious signs of shock with any lactate level evaluated by either two non-specialist physicians (e.g. registrar medical doctors) or a specialist physician.
- 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.
Who cannot join
- Cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician.
- Fertile women (<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG or women breastfeeding.
- Patient deemed terminally ill or with a severe co-morbid status resulting in non-eligibility for ICU admittance decided by either the treating physician or ICU consultant.
- Known allergy to noradrenaline.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Denmark5 sites, 4 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, 2400
Jens H. Rasmussen, MD, PhD
Jens H. Rasmussen, MD
- Terminated
Esbjerg Hospital
Esbjerg, 6700
- Not yet recruiting
Gødstrup Regional Hospital
Herning, 7400
Malik Kalmriz, MD, PhD
Malik Kalmriz, MD, PhD
- Recruiting
Zealand University Hospital
Køge, 4600
Gerhard Tiwald, MD, DMSc
Gerhard Tiwald, MD, DMSc
- Recruiting
Odense University Hospital
Odense, 5000
Lasse P Bentsen, MD
Lasse P Bentsen, MD
Sweden3 sites, 3 recruiting
- Not yet recruiting
Department of Emergency Medicine
Helsingborg, 25223
Jakob Lundager Forberg, MD
Jakob Lundager Forberg, MD, PhD
- Not yet recruiting
Department of Emergency Medicine
Linköping, 58185
Daniel Wilhelms, MD
Daniel Wilhelms, MD
- Not yet recruiting
Department of Emergency Medicine
Ystad, 27133
Rachel Keeling, MD
Rachel Keeling, MD
About this study
Official title: Early Initiated Vasopressor Therapy vs. Standard Care of Primarily Fluid Therapy in Hypotensive Patients in the Emergency Department - A Pragmatic, Multi-center, Superiority, Randomized Controlled Trial
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:
Read more
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.
Read the detailed description
Please refer to the full protocol.
- Conditions
- Shock, Shock, Septic, Hypotension, Hypotension and Shock, Hypotension Symptomatic, Hypovolemia
- Being tested
- Noradrenaline
- Keywords
- Peripherally infused noradrenaline, Fluid therapy, Fluid treatment, Non-hemorrhagic shock and hypotension, Emergency Department
- Medical subject headings
- Shock, Shock, Septic, Hypotension, Hypovolemia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoradrenalineDrug
Also called ATC-code C01CA03
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Noradrenaline |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 90 minutes
Secondary outcomes (4)
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.
Measured: 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.
Measured: At 24 hours
30-day all-cause mortality
Data is extracted from the Danish national registries or the patient's electronic medical records.
Measured: At 30 days
In-hospital all-cause mortality
Data is extracted from the Danish national registries or the patient's electronic medical records.
Measured: At hospital discharge, an average of 30 days efter inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start8 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lasse Paludan Bentsen, MD, Odense University Hospital
- Investigators
- Lasse P Bentsen, MD, Principal investigator, Department of Emergency Medicine, Odense University HospitalMikkel Brabrand, MD, PhD, Study chair, Department of Emergency Medicine, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931601
- Sponsor's protocol ID
- OP_1749
- Other IDs
- 2023-504584-16-00, 2023
- Acronym
- VASOSHOCK
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40197397
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Initiated Vasopressor Therapy vs. Standard Care of Primarily Fluid Therapy in Hypotensive Patients in the Emergency Department - A Pragmatic, Multi-center, Superiority, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05931601
- Acronym / sponsor ID
- VASOSHOCK / OP_1749
- Conditions
- Shock, Shock, Septic, Hypotension, Hypotension and Shock, Hypotension Symptomatic, Hypovolemia
- Keywords
- Peripherally infused noradrenaline, Fluid therapy, Fluid treatment, Non-hemorrhagic shock and hypotension, Emergency Department
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please refer to the full protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: NoradrenalinePeripheral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- Cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician.
- Fertile women (<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG or women breastfeeding.
- Patient deemed terminally ill or with a severe co-morbid status resulting in non-eligibility for ICU admittance decided by either the treating physician or ICU consultant.
- Known allergy to noradrenaline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NoradrenalineAlso: ATC-code C01CA03See arm description | Drug | Intervention |
Primary outcome
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.
Time frame: At 90 minutes
Bed-side assessment during treatment and registered in the case report form.
4 secondary outcomes
Number of intensive care unit (ICU) free days alive within 30 days
Time frame: At 30 days
Time without shock within 24 hours
Time frame: At 24 hours
30-day all-cause mortality
Time frame: At 30 days
In-hospital all-cause mortality
Time frame: At hospital discharge, an average of 30 days efter inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Background: PubMed 40197397Bentsen 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lasse P Bentsen, MD principal investigator
Department of Emergency Medicine, Odense University Hospital
Mikkel Brabrand, MD, PhD study chair
Department of Emergency Medicine, Odense University Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Noradrenaline in people with Shock and Shock, Septic, run by Odense University Hospital at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lasse P Bentsen, MD (+4520496950, lasse.paludan.bentsen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: At 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05931601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.