Early treatment with noradrenaline for shock in emergency departments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of early initiated peripheral infusion of noradrenaline compared to standard fluid therapy in patients experiencing hypotension and shock in Danish Emergency Departments. It is a pragmatic, multi-center, superiority, randomized trial that will assess outcomes such as time to shock control, ICU admission rates, and mortality. Participants will receive either noradrenaline or usual treatment urgently upon presentation, and their health data will be collected for analysis. Follow-up will occur one year after treatment to gather additional patient-reported outcomes.

Why it matters

Who can join: the full rules

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:

  1. SBP \< 100mmHg or MAP \< 65 mmHg combined with lactate \> 2.0 mmol/L,
  2. Physician defined blood pressure for the individual patient combined with a lactate \> 2.0 mmol/L
  3. 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.

Exclusion Criteria:

* 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.

Where it's running

• Bispebjerg Hospital
  Copenhagen, Denmark Recruiting
• Zealand University Hospital
  Køge, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Esbjerg Hospital
  Esbjerg, Denmark Terminated
• Gødstrup Regional Hospital
  Herning, Denmark Not yet recruiting
• Department of Emergency Medicine
  Helsingborg, Sweden Not yet recruiting

Study contacts

• Principal investigator: Lasse P Bentsen, MD — Department of Emergency Medicine, Odense University Hospital
• Study coordinator: Lasse P Bentsen, MD
• Email: lasse.paludan.bentsen@rsyd.dk
• Phone: +4520496950

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.