Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis (ARISE FLUIDS)

Australian and New Zealand Intensive Care Research Centre

Status and phase: Active, not recruiting; Phase 3

Conditions: Shock, Septic

Treatments: Other: Fluids; Drug: Vasopressor

Study type: Interventional

Funder types: Other

Identifiers

NCT04569942

ANZIC-RC/SP002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Vasopressor

Active Comparator group

Description:

a restricted fluids and early vasopressor strategy

Treatment:

Drug: Vasopressor

Fluids

Active Comparator group

Description:

a larger intravenous (IV) fluid volume and later vasopressor strategy

Treatment:

Other: Fluids