Early Initiated Vasopressor Therapy in the Emergency Department

Официальное название

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

Обзор

The goal of this pragmatic, multi-center, superiority, randomized clinical trial is to compare early treatment with peripheral (through a vein) infused noradrenaline (a natural hormone that increases blood pressure) with fluid only therapy in patients with hypotensive and shock in the Danish and Swedish Emergency Departments (ED). The main questions it aims to answer are: If early initiated noradrenaline in non-bleeding hypotensive patients presenting in the ED can * Improve time to shock control. * Reduce the need for ICU admittance. * Decrease mortality. Participants will be included by the clinical staff and treated urgently with either noradrenaline or usual treatment during their Emergency Department stay. After completion of the treatment in the Emergency Department, patient data will be extracted from the bed-side measurements, electronic health records and national registers. Patients will be contacted by the research staff 1 year after study inclusion to answer brief questions about their daily physical function and ability to care for themselves. Researchers will compare with patients receiving fluid therapy only, as this is the usual standard of care in Danish and Swedish Emergency Departments.

Подробное описание

Please refer to the full protocol.

Вмешательства

• Препарат Noradrenaline
  See arm description

Первичные конечные точки

• The primary outcome is the proportion of patients achieving either SBP >100 mmHg or MAP > 65 mmHg or a target blood pressure set by the treating physician at 90 (±15) minutes after inclusion. [Срок оценки: At 90 minutes]

Вторичные конечные точки (4)

• Number of intensive care unit (ICU) free days alive within 30 days [Срок оценки: At 30 days]
• Time without shock within 24 hours [Срок оценки: At 24 hours]
• 30-day all-cause mortality [Срок оценки: At 30 days]
• In-hospital all-cause mortality [Срок оценки: At hospital discharge, an average of 30 days efter inclusion]

Критерии участия

Критерии включения

• 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:

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 5 центров

• Bispebjerg Hospital — Copenhagen
• Esbjerg Hospital — Esbjerg
• Gødstrup Regional Hospital — Herning
• Zealand University Hospital — Køge
• Odense University Hospital — Odense

Швеция · 3 центра

• Department of Emergency Medicine — Helsingborg
• Department of Emergency Medicine — Linköping
• Department of Emergency Medicine — Ystad

Публикации

• Bentsen LP, Strom T, Forberg JL, Tiwald G, Biesenbach P, Kalmriz M, Rasmussen JH, Raaber N, Moller S, Lokke M, Tygesen GB, Nygaard H, Brok JH, Andersen JW, Bajusz N, Brabrand M. Early initiated noradrenaline versus fluid therapy for hypotension and shock in the emergency department (VASOSHOCK): a protocol for a pragmatic, multi-center, superiority, randomized controlled trial. Scand J Trauma Resus PMID 40197397

Идентификаторы

NCT: NCT05931601 · OP_1749 · 2023-504584-16-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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