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Early Initiated Vasopressor Therapy in the Emergency Department - A Multi-center Randomized Controlled Trial (VASOSHOCK)
EU CTIS ID: 2023-504584-16-00
What this study is testing
The aim is to investigate whether the use of early initiated vasopressor therapy (i.e., noradrenaline) compared to fluid therapy alone in non-bleeding hypotensive patients presenting in the ED can improve time to shock control and by that, reduce the need for ICU admittance.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 exclusion criteria) defined as: a. SBP < 100mmHg or MAP < 65 mmHg combined with lactate > 2.0 mmol/L, b. Physician defined blood pressure for the individual patient combined with a lactate > 2.0 mmol/L c. 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)
- Clinical Frailty Score (CFS), see appendix 2, 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.
You likely can't join if
- Cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician.
- Known or suspected pregnancy
- 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.
- Severe organ failure outside circulatory failure that requires immediate ICU admission.
- Previously enrolled in the trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.