Evaluating fluid versus vasopressor treatment for septic shock in emergency departments

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

This study is testing whether giving less fluid and starting medication sooner is better for people with septic shock in emergency departments compared to giving more fluid first and adding medication later.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Australian and New Zealand Intensive Care Research Centre (Academic / other)
• Locations: 19 sites (Bankstown, New South Wales and 18 other locations)
• Trial ID: NCT04569942 on ClinicalTrials.gov

What this trial studies

This multicentre, randomised controlled trial will enroll 1000 patients with septic shock in emergency departments across Australia and New Zealand. Participants will be assigned to receive either a restricted fluid and early vasopressor regimen or a larger initial IV fluid volume with vasopressors introduced later if needed. The intervention will be administered for at least 6 hours and up to 24 hours, with follow-up assessments conducted for up to 12 months. The study aims to determine the most effective resuscitation strategy for patients presenting with septic shock.

Who should consider this trial

Good fit: Ideal candidates for this study are adults presenting with septic shock and meeting specific clinical criteria.

Not a fit: Patients under 18 years old or those with hypotension from non-sepsis causes will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with septic shock by identifying the most effective resuscitation strategy.

How similar studies have performed: Previous studies have explored fluid and vasopressor strategies in septic shock, but this specific approach is being evaluated in a novel context.

Eligibility 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.

Where this trial is running

Bankstown, New South Wales and 18 other locations

• Bankstown Hospital — Bankstown, New South Wales, Australia (Recruiting)
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
• John Hunter Hospital — New Lambton Heights, New South Wales, Australia (Recruiting)
• Royal North Shore Hosptial — Sydney, New South Wales, Australia (Recruiting)
• Mackay Base Hospital — Mackay, Queensland, Australia (Recruiting)
• Robina Hospital — Robina, Queensland, Australia (Recruiting)
• Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
• Toowoomba Hospital — Toowoomba, Queensland, Australia (Recruiting)
• The Queen Elizabeth Hospital — Adelaide, South Australia, Australia (Recruiting)
• Bendigo Hospital — Bendigo, Victoria, Australia (Recruiting)
• Box Hill Hospital — Box Hill, Victoria, Australia (Not_yet_recruiting)
• Angliss Hospital — Ferntree Gully, Victoria, Australia (Not_yet_recruiting)
• Austin Health — Heidelberg, Victoria, Australia (Not_yet_recruiting)
• Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
• Maroondah Hospital — Ringwood East, Victoria, Australia (Not_yet_recruiting)
• St John of God Murdoch Hospital — Murdoch, Western Australia, Australia (Recruiting)
• Royal Perth Hospital — Perth, Western Australia, Australia (Recruiting)
• St. Vincent's University Hospital — Elm Park, Dublin, Ireland (Recruiting)
• Auckland City Hospital — Auckland, North Island, New Zealand (Recruiting)

Study contacts

• Study coordinator: Belinda D Howe, MPH

Conditions Shock, Septic; septic shock; vasopressor; Resuscitation Fluids