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

Who is this study for? Patients with Septic Shock
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
The Queen Elizabeth Hospital
RECRUITING
Adelaide
Bankstown Hospital
RECRUITING
Bankstown
Bendigo Hospital
RECRUITING
Bendigo
Box Hill Hospital
NOT_YET_RECRUITING
Box Hill
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Angliss Hospital
NOT_YET_RECRUITING
Ferntree Gully
Austin Health
NOT_YET_RECRUITING
Heidelberg
Mackay Base Hospital
RECRUITING
Mackay
Alfred Hospital
RECRUITING
Melbourne
St John of God Murdoch Hospital
RECRUITING
Murdoch
John Hunter Hospital
RECRUITING
New Lambton Heights
Royal Perth Hospital
RECRUITING
Perth
Maroondah Hospital
NOT_YET_RECRUITING
Ringwood East
Robina Hospital
RECRUITING
Robina
Gold Coast University Hospital
RECRUITING
Southport
Royal North Shore Hosptial
RECRUITING
Sydney
Toowoomba Hospital
RECRUITING
Toowoomba
Ireland
St. Vincent's University Hospital
RECRUITING
Elm Park
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Contact Information
Primary
Belinda D Howe, MPH
belinda.howe@monash.edu
0399030340
Time Frame
Start Date: 2021-10-26
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1000
Treatments
Active_comparator: Vasopressor
a restricted fluids and early vasopressor strategy
Active_comparator: Fluids
a larger intravenous (IV) fluid volume and later vasopressor strategy
Related Therapeutic Areas
Sponsors
Leads: Australian and New Zealand Intensive Care Research Centre

This content was sourced from clinicaltrials.gov