About this trial
The LIAISE study is a prospective observational study comparing the performance of load-incorporating echocardiographic parameters and conventional parameters in predicting adverse events among adult patients presenting to the ICU with sepsis. It will be conducted in hospitals in Australia, Hong Kong, South Africa, and Canada, with 199 patients recruited over 2 years. All included patients will receive an regular echocardiographic assessment and their haemodynamic parameters will be simultaneously recorded. Participants will be followed for up to 1 year after enrolment. Load incorporating parameters will be derived from regularly obtained echocardiography and haemodynamic data during offline analysis. The predictive value of cardiac parameters will be evaluated based on their statistical association with clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years old.
Clinically suspected of defined sepsis
Sepsis-induced hypotension or hypoperfusion (arterial or venous blood lactate ≥2.0 mmol/L OR mean artery pressure ≤65 mmHg over 30 mins OR at least one vasoactive or inotropic agent administered).
At least one dose of an IV antimicrobial has been commenced.
Disqualifiers
Suspected or confirmed pregnancy.
Any severe concomitant diseases with limited life expectancy <30 days.
Trial population
Patients with sepsis and hypotension / hypoperfusion signs, admitted for ICU
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
All cause death
Secondary outcomes
All cause death and adverse cardiac event readmission
Incidence of and time to all-cause death or adverse cardiac event readmissions for 1 year after ICU admission
Mechanical circulartory suport, mechanical ventilation, renal replacement therapy, and vasoactive/inotropic agent therapy
Incidence and duration (days) of mechanical circulatory support, mechanical ventilation, renal replacement therapy, and vasoactive agent therapy during initial admission
Reversibility of cardiac function
Left ventricular ejection fraction increases ≥ 5% in echo from 3-5 days after ICU admission
Sequential Organ Failure Assessment score at 3 days after ICU admission
Sequential Organ Failure Assessment score at Day 3 of index ICU admission will be assessed on a scale from 0 to 24, with higher scores indicating more severe organ failure.
Other outcomes
lengh of hosiptal or ICU stay
In-hospital mortariy
Vasoactive-inotropic score at 24, and 48 hours
Amount of fluid administered for the first 24 hours in ICU admission
CSL
Sponsors and contacts
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The University of Queensland
Lead sponsor
Queen Mary Hospital, Hong Kong
Collaborator
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