Clinical trial
Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis
Name
ANZIC-RC/SP002
Description
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 arms
Trial start
2021-10-26
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Vasopressor
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.
Arms:
Fluids
Size
1000
Primary endpoint
Days alive and out of hospital
From randomisation until 90 days post- randomization
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}
Updated at
2023-10-26
1 organization
1 product
2 indications
Product
VasopressorIndication
ShockIndication
Septicemia