BridgeMD
New treatment option for Shock
Official title Early Initiated Vasopressor Therapy in the Emergency Department
ClinicalTrials.gov ID: NCT05931601
What this study is testing
What is Noradrenaline?
Noradrenaline is an investigational medicine, given as an once-daily, being studied as a potential treatment for shock.
Also referred to as ATC-code C01CA03.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- ) defined as:
- SBP \ 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...
- 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...
See the full eligibility 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
- ) defined as:
- SBP \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Esbjerg, Denmark
- Herning, Denmark
- Køge, Denmark
- Odense, Denmark
- Helsingborg, Sweden
- Linköping, Sweden
- Ystad, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Esbjerg, Denmark; Herning, Denmark; Køge, Denmark; Odense, Denmark; Helsingborg, Sweden and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.