Load Incorporating Cardiac Assessment by Echocardiography In Patients With SEpsis (LIAISE Study)

ConditionSepsis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe University of Queensland

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Sepsis with hypotension or signs of hypoperfusion admitted to ICU

Trial outcomes

Primary outcomes

1

All cause death

Time frame
Day 30 after ICU admission

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

lengh of hosiptal or ICU stay

Time frame
during the initial index admission, between Day 0 and Day 30
2

In-hospital mortariy

Time frame
during the initial index admission, between Day 0 and Day 30
3

Vasoactive-inotropic score at 24, and 48 hours

Time frame
at 24 hour and 48 hour of index ICU admission
4

Amount of fluid administered for the first 24 hours in ICU admission

CSL

Time frame
Day 1 of index ICU admission

Sponsors and contacts

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The University of Queensland

Lead sponsor

Queen Mary Hospital, Hong Kong

Collaborator

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