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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04569942




Registration number
NCT04569942
Ethics application status
Date submitted
23/09/2020
Date registered
30/09/2020
Date last updated
12/03/2021

Titles & IDs
Public title
Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis
Scientific title
Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis
Secondary ID [1] 0 0
ANZIC-RC/SP002
Universal Trial Number (UTN)
Trial acronym
ARISE FLUIDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shock, Septic 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vasopressor
Other interventions - Fluids

Active Comparator: Vasopressor - a restricted fluids and early vasopressor strategy

Active Comparator: Fluids - a larger intravenous (IV) fluid volume and later vasopressor strategy


Treatment: Drugs: 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 interventions: 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.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days alive and out of hospital - the number of days alive and out of hospital at 90 days post randomization
Timepoint [1] 0 0
From randomisation until 90 days post- randomization
Secondary outcome [1] 0 0
Mortality - All-cause mortality
Timepoint [1] 0 0
From randomisation until 90 days post- randomization
Secondary outcome [2] 0 0
Time from randomization until death - Time from randomization until death
Timepoint [2] 0 0
From randomisation until 90 days post- randomization
Secondary outcome [3] 0 0
Days alive and at home - Days alive and at home at 90 days post-randomisation
Timepoint [3] 0 0
From randomisation until 90 days post- randomization
Secondary outcome [4] 0 0
Ventilator-free days to day 28 - Number of days not on invasive mechanical ventilation
Timepoint [4] 0 0
From randomisation until 28 days post- randomization
Secondary outcome [5] 0 0
Vasopressor-free days to day 28 - Number of days not on vasopressors
Timepoint [5] 0 0
From randomisation until 28 days post- randomization
Secondary outcome [6] 0 0
Renal replacement therapy-free days to day 28 - Number of days not on renal replacement therapy
Timepoint [6] 0 0
From randomisation until 28 days post- randomization
Secondary outcome [7] 0 0
Death or disability at 6 months - Death or disability as measured by the World Health Organization Disability Assessment Schedule (WHODAS)
Timepoint [7] 0 0
at 6 months post randomization
Secondary outcome [8] 0 0
Death or disability at 12 months - Death or disability as measured by the World Health Organization Disability Assessment Schedule (WHODAS)
Timepoint [8] 0 0
at 12 months post randomization

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hosptial - Sydney
Recruitment hospital [2] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04569942
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04569942