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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

October 26, 2021

Primary Completion Date

October 31, 2025

Study Completion Date

December 31, 2026

Conditions
Shock, Septic
Interventions
DRUG

Vasopressor

Cease IV fluid resuscitation. If persisting hypotension and/or hypoperfusion commence a vasopressor infusion (e.g. noradrenaline) and titrate according to local practice to achieve target MAP. The target MAP will be determined by the treating clinician. Reassess at least hourly for up to 6 hours post-randomisation, then as clinically required in conjunction with the protocol. Boluses of 250ml of IV fluids are permitted if deemed indicated by the treating clinician.

OTHER

Fluids

An fluid bolus of up to 1000ml will be administered over a maximum of 1 hour, if required, for persisting hypotension and/or hypoperfusion. Reassess at least hourly to 6 hours post-randomisation, then as clinically required in conjunction with the protocol. Further IV fluid boluses of 500ml are recommended as clinically indicated to achieve the target MAP. The target MAP will be determined by the treating clinician. Haemodynamic resuscitation will be guided by usual clinical assessment including vital signs, mentation, perfusion, and urine output until the treating clinician determines fluid resuscitation is no longer clinically required. A minimum of 2-3 L (30 ml/kg), including pre-randomisation fluids, is recommended within 3 hours of ED arrival consistent with the SSC guidelines, unless clinically contraindicated. Vasopressors may be commenced if blood pressure remains below target despite optimal fluid resuscitation as determined by the treating clinician.

Trial Locations (19)

1023

RECRUITING

Auckland City Hospital, Auckland

2050

RECRUITING

Royal Prince Alfred Hospital, Camperdown

2065

RECRUITING

Royal North Shore Hosptial, Sydney

2200

RECRUITING

Bankstown Hospital, Bankstown

2305

RECRUITING

John Hunter Hospital, New Lambton Heights

3004

RECRUITING

Alfred Hospital, Melbourne

3084

NOT_YET_RECRUITING

Austin Health, Heidelberg

3128

NOT_YET_RECRUITING

Box Hill Hospital, Box Hill

3135

NOT_YET_RECRUITING

Maroondah Hospital, Ringwood East

3156

NOT_YET_RECRUITING

Angliss Hospital, Ferntree Gully

3550

RECRUITING

Bendigo Hospital, Bendigo

4215

RECRUITING

Gold Coast University Hospital, Southport

4226

RECRUITING

Robina Hospital, Robina

4350

RECRUITING

Toowoomba Hospital, Toowoomba

4740

RECRUITING

Mackay Base Hospital, Mackay

5011

RECRUITING

The Queen Elizabeth Hospital, Adelaide

6000

RECRUITING

Royal Perth Hospital, Perth

6150

RECRUITING

St John of God Murdoch Hospital, Murdoch

D04 T6F4

RECRUITING

St. Vincent's University Hospital, Elm Park

All Listed Sponsors
lead

Australian and New Zealand Intensive Care Research Centre

OTHER