Restricted or Liberal Fluid for Haemodynamic Resuscitation in Sepsis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAustralian and New Zealand Intensive Care Research Centre
About this trial
A prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspected or proven infection
Systolic blood pressure (SBP) <100 mm Hg OR mean arterial pressure (MAP) <65 mm Hg
Lactate ≥ 2.0 mmol/L
Requirement for vasopressors to meet perfusion targets
Disqualifiers
None
Trial population
All trials include adult patients requiring resuscitation for hypotension or hypoperfusion due to suspected sepsis as defined in the original studies. Participants may be enrolled in the emergency department, acute care ward or intensive care unit.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Vasopressors
Other interventionA haemodynamic resuscitation strategy based upon the restriction of IV fluids (by either volume or rate of infusion) with initiation or change of rate of vasopressors if required to meet perfusion targets
Fluids
Other interventionA strategy of resuscitation with intravenous fluids as the primary intervention to achieve perfusion targets with subsequent initiation or change of rate of vasopressors if required.
Treatment groups
7,838 Participants
are divided into 2 treatment groupsGroup A: Vasopressors1 intervention
Group B: Fluids1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality at 90 days post randomisation
Death from any cause at 90 days after randomisation
Time frame
90 daysSecondary outcomes
1
Time from randomisation to death
Time from randomisation to death
Time frame
Up to day 902
Incidence of mechanical ventilation
Commencement of mechanical ventilation from randomisation until day 90 post-randomisation
Time frame
from randomisation until day 90 post-randomisation3
Incidence of acute renal replacement therapy
Commencement of renal replacement therapy from randomisation until day 90 post-randomisation
Time frame
from randomisation until day 90 post-randomisation4
Days alive free of organ support at 28 days post randomisation
days the patient is alive and receiving nil organ support from from randomisation until day 28 post-randomisation
Time frame
from randomisation until day 28 post-randomisationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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