Early Initiated Vasopressor Therapy in the Emergency Department

Launched by ODENSE UNIVERSITY HOSPITAL · Jun 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of starting treatment with noradrenaline, a hormone that helps raise blood pressure, early in patients who are experiencing low blood pressure or shock when they arrive at the Emergency Department (ED). The goal is to see if this early treatment can help control shock faster, reduce the need for intensive care unit (ICU) admission, and lower the risk of death compared to the usual treatment, which is just giving fluids.

To be eligible for this trial, participants must be at least 18 years old and show signs of low blood pressure or shock. They should have received at least 500 milliliters of fluid before joining the study. Patients will be treated urgently with either noradrenaline or the usual fluid therapy, and their health will be monitored closely during their stay in the ED. After one year, researchers will follow up with participants to learn about their recovery and daily activities. This trial is currently recruiting patients and aims to provide valuable information about improving treatment for those in critical condition.

Gender

ALL

Eligibility 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.