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ER shock showdown: less fluid, early pressors vs. standard care

NCT ID NCT04569942

Disease control Sponsor: Australian and New Zealand Intensive Care Research Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two strategies for treating septic shock in the emergency department. One group gets less IV fluid and starts blood-pressure-raising drugs (vasopressors) early. The other group gets more IV fluid first, then vasopressors if needed. The trial includes 1000 patients across Australia and New Zealand and tracks how many days they are alive and out of the hospital up to 90 days later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vasopressors (e.g., noradrenaline) and IV fluids
What this could lead to
If it works, this could show that using vasopressors early with less fluid is a better way to treat septic shock, potentially improving survival and recovery.
What could go wrong
This is a large phase 3 trial, but results may not apply to all sepsis patients. The best approach may depend on individual patient factors, and there are risks from both too little fluid and from vasopressors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,000 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Shock, septic

Contacts and locations

Locations

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • Angliss Hospital

    Ferntree Gully, Victoria, 3156, Australia

  • Auckland City Hospital

    Auckland, North Island, 1023, New Zealand

  • Ballarat Base Hospital

    Ballarat, Victoria, 3353, Australia

  • Bankstown Hospital

    Bankstown, New South Wales, 2200, Australia

  • Barwon Health Geelong Hospital

    Geelong, Victoria, 3220, Australia

  • Bendigo Hospital

    Bendigo, Victoria, 3550, Australia

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Bunbury Hospital

    Bunbury, Western Australia, 6230, Australia

  • Bundaberg Hospital

    Bundaberg, Queensland, 4670, Australia

  • Caboolture Hospital

    Caboolture, Queensland, 4510, Australia

  • Cairns Hospital

    Cairns, Queensland, 4870, Australia

  • Casey Hospital

    Berwick, Victoria, 3806, Australia

  • Dandenong Hospital

    Dandenong, Victoria, Australia

  • Dunedin Hospital

    Dunedin, Otago, 9054, New Zealand

  • Fiona Stanley Hospital

    Perth, Western Australia, 6150, Australia

  • Flinders Medical Centre

    Streaky Bay, South Australia, 5025, Australia

  • Gold Coast University Hospital

    Southport, Queensland, 4215, Australia

  • Hervey Bay Hospital

    Hervey Bay, Queensland, 4655, Australia

  • Ipswich Hospital

    Ipswich, Queensland, 4305, Australia

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305, Australia

  • Mackay Base Hospital

    Mackay, Queensland, 4740, Australia

  • Maroondah Hospital

    Ringwood East, Victoria, 3135, Australia

  • Middlemore Hospital

    Middlemore, Otahuhu, 1640, New Zealand

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • Nepean Hosital

    Kingswood, New South Wales, 2747, Australia

  • Northern Hospital

    Epping, Victoria, 3076, Australia

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444, Australia

  • QE II Jubilee Hospital

    Brisbane, Queensland, 4108, Australia

  • Robina Hospital

    Robina, Queensland, 4226, Australia

  • Royal Darwin & Palmerston Hospital

    Darwin, Northern Territory, 0811, Australia

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Royal North Shore Hosptial

    Sydney, New South Wales, 2065, Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Ryde Hospital

    Sydney, New South Wales, 2112, Australia

  • St John of God Hospital

    Midland, Western Australia, 6056, Australia

  • St John of God Murdoch Hospital

    Murdoch, Western Australia, 6150, Australia

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065, Australia

  • St. Vincent's University Hospital

    Elm Park, Dublin, D04 T6F4, Ireland

  • Sunshine Coast university hospital

    Sunshine Coast, Queensland, 4560, Australia

  • Tamworth Hospital

    Tamworth, New South Wales, 2340, Australia

  • Taranki Hospital

    Hawera, 4640, New Zealand

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032, Australia

  • The Queen Elizabeth Hospital

    Adelaide, South Australia, 5011, Australia

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350, Australia

  • Townsville Hospital

    Townsville, Queensland, 4810, Australia

  • Wangaratta Hospital

    Wangaratta, Victoria, 3677, Australia

  • Wellington Hospital

    Wellington, 2820, New Zealand

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.