Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 1,000
- Locations
- 98
- Primary Endpoint
- Days alive and out of hospital
Study Overview
Brief 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.
Detailed Description
The ARISE FLUIDS study is a multicentre, randomised, parallel group clinical trial of a restricted fluids and early vasopressor strategy compared to a larger initial IV fluid volume and later vasopressors for the haemodynamic resuscitation of patients with septic shock presenting to the ED. It will be conducted in hospitals in Australia and New Zealand with 1000 patients recruited over a 3-year period.
Each patient meeting all of the inclusion and none of the exclusion criteria will be randomised to receive haemodynamic resuscitation using either a restricted fluid and early vasopressor regimen (vasopressors arm) or a larger initial fluid resuscitation volume (fluids arm) followed by later introduction of vasopressors (if required). The intervention will be commenced in the ED and delivered for at least 6 hours, and up to 24 hours post-randomisation if admitted to the ICU or other critical care area where the study protocol can be faithfully delivered. Treatment will revert to usual care as determined by the treating clinician when the patient is transferred to a non-critical care ward. All enrolled participants will be followed up and assessed for the defined study outcomes.
Participants will be identified using a systematic approach to screening and assessment of patients with possible sepsis presenting to the ED in accordance with standard clinical practice.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Vasopressor
a restricted fluids and early vasopressor strategy
Intervention: Vasopressor (Drug)
Fluids
a larger intravenous (IV) fluid volume and later vasopressor strategy
Intervention: Fluids (Other)
Outcomes
Primary Outcomes
Days alive and out of hospital
Time Frame: From randomisation until 90 days post- randomization
the number of days alive and out of hospital at 90 days post randomization
Secondary Outcomes
- Death or disability at 6 months(at 6 months post randomization)
- Death or disability at 12 months(at 12 months post randomization)
- Time from randomization until death(From randomisation until 90 days post- randomization)
- Ventilator-free days to day 28(From randomisation until 28 days post- randomization)
- Vasopressor-free days to day 28(From randomisation until 28 days post- randomization)
- Days alive and at home(From randomisation until 90 days post- randomization)
- Mortality(From randomisation until 90 days post- randomization)
- Renal replacement therapy-free days to day 28(From randomisation until 28 days post- randomization)