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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-10-26

Primary completion: 2024-12-31

Study completion finish: 2025-12-31

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04569942

Intervention or treatment

DRUG: Vasopressor

OTHER: Fluids

Conditions

• Shock, Septic

Condition: Shock, Septic
DRUG: Vasopressor and other drugs
Camperdown, New South Wales, Australia and more
Sponsor: Australian and New Zealand Intensive Care Research Centre

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Royal Prince Alfred Hospital

Research sites nearby

Select from list below to view details:

Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Mackay Base Hospital
Mackay, Queensland, Australia
Robina Hospital
Robina, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Vasopressor a restricted fluids and early vasopressor strategy	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.
ACTIVE_COMPARATOR: Fluids a larger intravenous (IV) fluid volume and later vasopressor strategy	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.

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Vasopressor

a restricted fluids and early vasopressor strategy

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.

ACTIVE_COMPARATOR: Fluids

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

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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Days alive and out of hospital	the number of days alive and out of hospital at 90 days post randomization	From randomisation until 90 days post- randomization

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Mortality	All-cause mortality	From randomisation until 90 days post- randomization
Time from randomization until death	Time from randomization until death	From randomisation until 90 days post- randomization
Days alive and at home	Days alive and at home at 90 days post-randomisation	From randomisation until 90 days post- randomization
Ventilator-free days to day 28	Number of days not on invasive mechanical ventilation	From randomisation until 28 days post- randomization
Vasopressor-free days to day 28	Number of days not on vasopressors	From randomisation until 28 days post- randomization
Renal replacement therapy-free days to day 28	Number of days not on renal replacement therapy	From randomisation until 28 days post- randomization
Death or disability at 6 months	Death or disability as measured by the World Health Organization Disability Assessment Schedule (WHODAS)	at 6 months post randomization
Death or disability at 12 months	Death or disability as measured by the World Health Organization Disability Assessment Schedule (WHODAS)	at 12 months post randomization

Frequently Asked Questions

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References

Clinical Trials Gov: Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis