Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicentre, randomised controlled trial will enrol 1000 patients presenting with septic shock to the emergency department (ED) of participating hospitals in Australia and New Zealand. Participants will receive haemodynamic resuscitation with either a restricted fluids and early vasopressor regimen or a larger initial IV fluid volume with later introduction of vasopressors if required. Clinical care including the type of resuscitation fluid and vasopressor agent, will otherwise be in accordance with accepted standard care and according to clinician discretion. The study intervention will be delivered for at least 6 hours and up to 24 hours post-randomisation. Participants will be followed for up to 12 months and outcomes analysed on an intention-to-treat basis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Australian and New Zealand Intensive Care Research Centre
• Treatments: Vasoconstrictor Agents

Criteria

Inclusion Criteria:

• Clinically suspected infection;

• Systolic blood pressure (SBP) <90 mm Hg or mean arterial pressure (MAP) <65 mm Hg, despite a ⩾1000ml cumulative total bolus of IV fluid administered over a maximum of 60 minutes; including pre-hospital boluses;

• Arterial or venous blood lactate >2.0 mmol/L;

• At least one dose of an intravenous antimicrobial has been commenced.

Exclusion Criteria:

• Age <18 years;

• Confirmed or suspected pregnancy;

• Transferred from another acute care facility;

• Hypotension suspected to be due to a non-sepsis cause;

• >2L total IV fluid administered (including prehospital fluids but excluding drugs and flushes);

• More than 6 hours has elapsed since presentation to the ED or more than 2 hours has elapsed since last inclusion criterion has been met;

• Treating clinician considers that one or both of the treatment regimens are not suitable for the patient or the study protocol cannot be delivered e.g. limitation of care, requirement for immediate surgery;

• Death is considered imminent or inevitable;

• Underlying disease that makes survival to 90 days unlikely;

• Inability to follow patient up to day-90 e.g. unstable accommodation, overseas visitor;

• Previously enrolled in this study.