Early treatment with noradrenaline for shock in emergency departments
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
This study tests if giving noradrenaline right away helps people in shock feel better and recover faster than just using standard fluids.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 8 sites (Copenhagen and 7 other locations) |
| Trial ID | NCT05931601 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older presenting with signs of hypotension or shock who have received at least 500ml of intravenous fluid within the first 4 hours of emergency department arrival.
Not a fit: Patients with a Clinical Frailty Score of 5 or higher who are not suitable for ICU admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of hypotensive patients, potentially reducing mortality and ICU admissions.
How similar studies have performed: Other studies have shown promising results with early vasopressor therapy in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Copenhagen and 7 other locations
- Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
- Esbjerg Hospital — Esbjerg, Denmark (Terminated)
- Gødstrup Regional Hospital — Herning, Denmark (Not_yet_recruiting)
- Zealand University Hospital — Køge, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Department of Emergency Medicine — Helsingborg, Sweden (Not_yet_recruiting)
- Department of Emergency Medicine — Linköping, Sweden (Not_yet_recruiting)
- Department of Emergency Medicine — Ystad, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.