Early Initiated Vasopressor Therapy in the Emergency Department - A Multi-center Randomized Controlled Trial (VASOSHOCK)

Phase 1

Recruiting

• Conditions: Shock, Hypotension; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

• Registration Number: CTIS2023-504584-16-00
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 320

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: 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) within the first 4 hours of ED arrival., 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.

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified