1,000
Participants
Start Date
October 26, 2021
Primary Completion Date
October 31, 2025
Study Completion Date
December 31, 2026
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.
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.
RECRUITING
Auckland City Hospital, Auckland
RECRUITING
Royal Prince Alfred Hospital, Camperdown
RECRUITING
Royal North Shore Hosptial, Sydney
RECRUITING
Bankstown Hospital, Bankstown
RECRUITING
John Hunter Hospital, New Lambton Heights
RECRUITING
Alfred Hospital, Melbourne
NOT_YET_RECRUITING
Austin Health, Heidelberg
NOT_YET_RECRUITING
Box Hill Hospital, Box Hill
NOT_YET_RECRUITING
Maroondah Hospital, Ringwood East
NOT_YET_RECRUITING
Angliss Hospital, Ferntree Gully
RECRUITING
Bendigo Hospital, Bendigo
RECRUITING
Gold Coast University Hospital, Southport
RECRUITING
Robina Hospital, Robina
RECRUITING
Toowoomba Hospital, Toowoomba
RECRUITING
Mackay Base Hospital, Mackay
RECRUITING
The Queen Elizabeth Hospital, Adelaide
RECRUITING
Royal Perth Hospital, Perth
RECRUITING
St John of God Murdoch Hospital, Murdoch
RECRUITING
St. Vincent's University Hospital, Elm Park
Australian and New Zealand Intensive Care Research Centre
OTHER