An observational study in Sepsis, sponsored by The University of Queensland. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by The University of Queensland · Observational
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.
Background Sepsis is a global killer, whereby an infection spreads throughout the body via the bloodstream. It often leads to lethal heart damage, "septic cardiomyopathy", with mortality rates for those affected soaring above 40%. To facilitate early and appropriate intervention for damaged hearts and improve their outcomes, accurate assessment of heart function, and proper prediction of their adverse events are crucial. However, conventional cardiac assessments cannot capture heart dysfunction accurately since they have a significant limitation called "load-dependency", which means these parameters' values are affected by loading conditions on the heart, such as blood pressure and circulating blood volume. In sepsis, as these loads on the heart dramatically change minute by minute, the values of cardiac assessment also fluctuate and frequently underestimates heart damage, failing to properly predict their adverse events. To address this, novel load-incorporating echocardiographic parameters can capture heart function more accurately regardless of these hemodynamic conditions, and previous data has demonstrated its better predictive value in cardiogenic shock cases where loading conditions similarly fluctuate. As a next step, this study seeks to elucidate their utility in patients with sepsis.
Aims
Hypothesis Load-incorporating echocardiographic parameters will be more accurate in predicting the incidence of adverse events within 30 days after ICU admission than conventional echocardiographic parameters.
Outcomes Primary outcome The incidence of all-cause death for 30 days after ICU admission
Secondary outcomes
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →The University of Queensland is the lead sponsor of 89 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with sepsis and hypotension / hypoperfusion signs, admitted for ICU
Exclusion Criteria:
All cause death
Time frame: Day 30 after ICU admission
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
Time frame: 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
Time frame: during the initial index admission, between Day 0 and Day 30
Reversibility of cardiac function
Left ventricular ejection fraction increases ≥ 5% in echo from 3-5 days after ICU admission
Time frame: Day 3 to Day 5
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.
Time frame: at Day 3 of ICU admission
lengh of hosiptal or ICU stay
Time frame: during the initial index admission, between Day 0 and Day 30
In-hospital mortariy
Time frame: during the initial index admission, between Day 0 and Day 30
Vasoactive-inotropic score at 24, and 48 hours
Time frame: at 24 hour and 48 hour of index ICU admission
Amount of fluid administered for the first 24 hours in ICU admission
CSL
Time frame: Day 1 of index ICU admission
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Study Protocol Statistical Analysis Plan Informed Consent Form
Supporting information: Study protocol, Sap, Icf
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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The University of Queensland